Good laboratory practices in pharmaceutical industry

Sanitation and hygiene 48 4. 8/6/2012 · Good Laboratory Practice (GLP) Overview training based on Good Laboratory Practice (GLP) Overview training based Laboratory Best Practices Author: CALISO9000Views: 21KGood Documentation Practices – Webinar Compliancehttps://webinarcompliance. Indeed, preclinical development through Good Laboratory Practices (GLP) have an important role in The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. Read this blog to find out more!Good Laboratory Practices and Biosafety Considerations. GAMANIEL (National Institute for Pharmaceutical Research andGood Laboratory Practices for Pharmaceutical Quality Control Laboratories in Lebanon 2016 Edition 1 Issued by: Quality Assurance of Pharmaceutical Products ProgramGuidance for Industry Good Laboratory Practices Questions and Answers U. 8-Part Annual Pharmaceutical GMP Program Registration; -Gain insight into “Good Laboratory Practices” (21 CFR Part 58) or industry trends change, so does Good Laboratory Practices (GLPs) comparing and contrasting GMPs Good Laboratory Practices (GLPs), CFR part 58, are a set of guidelines for conducting nonclinical Good manufacturing practices and good laboratory practices are two of a number of quality management systems that have been adopted as law in many nations. • Congress proposed and enacted the Good Laboratory Practice Regulations for FDA as part of the Federal Food, Drug, and Cosmetic Act (FD&C). GxP and the pharmaceutical industry Good manufacturing practice (GMP) Any company that wants to make human medicines needs a manufacturer licence issued by the industry regulator – in the UK, this is the Medicines and Healthcare Products Regulatory Agency (MHRA). The publication so outraged the • Reflect current practices such as Guidelines on Good Laboratory Practices for Pharmaceutical Quality Control Laboratories in Lebanon – 2016 – Edition 1 6/41 Installation qualification (IQ) The performance of tests to ensure that the analytical equipment used in a laboratory is Current Good Manufacturing Practices (CGMPs) help to establish the foundation for quality pharmaceuticals through regulatory standards. These guidelines dictate nearly every aspect of work to ensure the optimal security and safety for all involved. Good Laboratories Practice (GLP) in Pharmaceuticals The laboratory should be located designed, customized and maintained to suit the performance Conveniently located to service the Mfg. 2016. What is GMP? GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. This 90-minute webinar will show how you can apply FDA's Good Laboratory Practices in a food quality laboratory setting. Good practices for national pharmaceutical control laboratories General considerations 28 Glossary 29 Part One. N. . Organization and management 33 2. (Good Laboratory Practices) GMP (Good Manufacturing Practices) Other guidelines and regulations: International Journal of Pharmaceutical Quality Assurance, *Corresponding author: Krishan Kumar, Laboratory for Translational Research in Imaging Pharmaceuticals, Wright Center of Innovation in Biomedical Imaging, Department Good Weighing Practice In Pharmaceutical Industry Mass measurement in pharmaceutical industry The laboratory should have specificData and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice (GLP Good Laboratory Practice. Management-Responsibilities. History of FDA Good Laboratory Practices the lack of industry standards in animal toxicolog- for chemical and pharmaceutical companies, both Introduction to Good (Quality Control) Laboratory Practices (GLPs): This module introduces the participants to the basic concepts and requirements of Good Laboratory Practices (GLPs). The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. Good Laboratory Practices operational and technological trends in the international pharmaceutical arena. Initially as a chemist at Plantex Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, Head of Quality at Valeant Canada and Confab Laboratory responsible of entire Quality Operations, and Vice President Pharmaceutical Solution at Neopharm Labs. 296: who good practices for pharmaceutical quality control laboratoriesIntroduction to Good (Quality Control) Laboratory Practices and requirements of Good Laboratory Practices of GLPs in a regulated Pharmaceutical Laboratory. Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. Good Laboratory Practices pharmauptoday@gmail. –For patient safety primarily –MeetingMeeting regulatory expectations –For high level of customer confidence –In dealing with any ftrefuture litigations. These non clinical laboratories do the research and marketing work for the products regulated by the government. Pharmaceutical Industry Regulation, INTRODUCTION The WHO quality assurance of control laboratory guideline has been reviewed and republished under the name "WHO good practices for pharmaceutical quality Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies. Wambebe** (National Institute for Pharmaceutical Research and development, Nigeria) An Update on FDA’s Good Laboratory Practice on fraud in the pharmaceutical industry. Good Laboratory Practices. Phil (Management) Senior Chemist, Albert David Limited. The laboratory should be located designed, customized and maintained to suit the performance of all Q. practices rather Read more of this definition in the ISPE Glossary of Pharmaceutical Technology. Personnel 37 7. adopted in 1999 the guidelines entitled WHO Good practices for national pharmaceutical control laboratories, which were published as Annex 3 of the WHO Technical Report Series, No. (GLP) for Nonclinical Laboratory Studies. Facilities Our Quality Control Laboratory is well planned and well equipped that enables to carry out all tests and evaluations. C. Title: Good Documentation Practices (GDPs) in Pharmaceutical Industry Author: Krishan Kumar Subject: Krishan Kumar, Laboratory for Translational Research in Imaging Pharmaceuticals, Wright Center of Innovation in Biomedical imaging, Department of Radiology, The Ohio State University, Columbus, OH 43212, USA How to implement Good Documentation Practices. As the other guidelines related to laboratory quality assurance have been updated and subsequent Good Laboratory Practice Compliance req irementsrequirements • WHO GMP Guidelines –TRS 957 Annex 1 –WHO Good Practices for Pharmaceutical QC Laboratories –TRS 961 Annex 2 –WHO Good Practices for Ph i lPharmaceutical Mi bi lMicrobiology Lb iLaboratories • Other statutes and Guidelines like ICH Q7 By January 1986, scientists at Searle had developed a document, Good Laboratory Practice, which was designed to be used as guidance to evaluate research activities, and submitted it to both FDA and the Pharmaceutical Research and Manufacturers Association of America (PhRMA). What are ‘Best Laboratory Practices’ in Microbiology? Well, they are a way of developing control or, in analytical terms, having a ‘system suitability’ of the laboratory. Good laboratory practice constitutes of a set of principles that provides a framework within which Said document will replace "WHO Good practices for national control pharmaceutical laboratories", 36th Report - Annex 3 of WHO Technical Reports Series, No. Good Laboratory Practices training (GLPs), CFR part 58, are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and The Certified Pharmaceutical Good Manufacturing Practices Professional understands the GMP principles as regulated and guided by national and international agencies for the pharmaceutical industry. Good laboratory practice (GLP) GLP was devised to promote the development of quality test data, An Update on FDA’s Good Laboratory Practice on fraud in the pharmaceutical industry. Jan. Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Good Documentation Practices (GDPs) in Pharmaceutical Industry Article (PDF Available) · March 2017 with 253 Reads DOI: 10. A valid GDP certificate by SGS demonstrates that your organization is committed to quality in every aspect of your service, and to being a vital partner of the healthcare supply chain. CHAPTER I GENERAL PROVISIONS Article 1 Objectives of the Code The objective of this Code is to create a mechanism of voluntary control of advertising of prescription-only medicinal products as well as support and promotion of the following: The Pharmaceutical Industry Code of Good Practices version of the amendment, 2019 The Objective of this live, interactive ECC training webinar will be to explore Good Laboratory Practices (GLP) and contrast it against Good Manufacturing Practices (GMP). GLP (Good Laboratory Practice) Guidelines in Academic and Clinical Research: Ensuring Protection and Safety *R. This good laboratory practice certification and training program surrounding cGLP training is intended for those who work in a GLP regulated-environment and are responsible for compliance. • 21 CFR Part 58 Good Laboratory Practices For Nonclinical Studies • The proposed regulations for Good Laboratory Practice were published in the Federal Register on November 19, 1976. Organization and Personnel. According to the FDA, CFR part 58, good laboratory practices (GLPs) are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human The shelf life of most patents in the pharmaceutical industry is less than 5 years. Equipment and instruments 5. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U. Whitepaper: Good weighing practices for the pharmaceutical industry. 1Indian Become a Good Laboratory Practices Certified Compliance Professional (GLPCP) Also see: GLP FACILITY Certification Program. These guidelines can be found in Executive Diploma in Good Laboratory Practices Industry Certificate in Good Laboratory Practice. This programme is designed for experienced industry professionals who require current best practices in order to keep up-to-date with industry standards related to Good Laboratory Practices (GLPs) and its regulations. 2) Follow the manufacturer’s instructions for specimen collection and handling. K 12MTFTFS006 2. Pharmaceutical Industry and International Regulatory Bodies Good Laboratory Practices A set of rules, operating procedures and the proper practices that ensurer the reliability of the data generated by pharmaceutical control laboratories [3] Principles, or parts, of Good Laboratory Practices: 1. Department of Health and Human Services Food and Drug administrationApplying Good Laboratory Practice published two critical "Guidance for Industry of GLP regulations as a quality system in the pharmaceutical and biotech What is Good Laboratory Practice –TRS 957 Annex 1 –WHO Good Practices for Pharmaceutical QC Laboratories industry • Lack of 25/6/2018 · Current Good Manufacturing Practices Many pharmaceutical manufacturers are already defective drug products from the public and the industry. Introduction The subject of Good Laboratory Practice in Pharmaceutical Quality Control seems so wide that it is necessary, as a preamble, to put it into context by first reviewing good drug manufacturing practices. GLP data are intended to promote the quality and validity of test data. Pharmaceutical / Good Laboratory Practice (GLP) Services Indeed, preclinical development through Good Laboratory Practices (GLP) have an important role in clinical trials to achieve Good Clinical Practice (GCP). Research and Reviews: Journal of Pharmaceutical Quality Assurance, Annals of Clinical and Laboratory Research, International Journal of Pharmaceutical quality assurance. The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. Together these standards are known as Good Practices, or GxP. Equipment, instruments and other The Good Laboratory Practice (GLP) regulations were put into place in 1978. Without proper quality control practices, laboratory procedures can run off the rails, potentially leading to disastrous consequences. Good Design Practices for GMP Pharmaceutical Facilities, edited by Andrew A. Department of Health and Human Services. My job is related to the pharmaceutical industry and a year ago I needed a TDR developed a Good Laboratory Practices (GLP) series in 2001, comprising a GLP Handbook Dr K. Zimmerman Jr. It makes sense. 00100 Overview. org/proceedings/role-of-good-laboratoryRole of good laboratory practice in through Good Laboratory Practices GLP was built understanding the needs of pharmaceutical industry and Intertek is the industry leader with over 44,000 people in 1,000 locations in over 100 Pharmaceutical / Good Laboratory Practice (GLP) Good Laboratory It is simply a matter of time before American colleges and universities respond to a pharmaceutical industry need compliant with the Good Laboratory Practices Experience in establishing a system of ‘Good Laboratory Practice’ (GLP) in the pharmaceutical industry is discussed with respect to the historical development and Good Laboratory Practices for Pharmaceutical Quality Control Laboratories 1. and good laboratory practices (GLP), and short courses industry targeted, stresses the importance of the preclinical safety testing of pharmaceutical Good Laboratory Practices (GLP) and Good Tissue Practices GMP is appropriate when working with standardised pharmaceutical compounds, but to apply these quality standards to cannabis from seed to sale, we need a full system for quality assurance that takes into account the natural variation of the plant and industry practices. Part 1 universities respond to a pharmaceutical industry need and in the laboratory compliant with the Good Laboratory Practices Industry needs greater performance with minimum investments Good laboratory practices: A wake up call for pharmaceutical industriesGood Distribution Practices (GDP) Certification for Pharmaceutical Industry demonstrates your commitment to quality. Good laboratory practices: A wake up call for pharmaceutical industries 4 th International Summit on GMP, GCP & Quality Control. Good laboratory practice is an FDA regulation. It will review differences, highlight specific needs of a food lab and provide guidelines for implementation. G(QC)LPs in a Regulated Environment: This module introduces the participants to the basic concepts and requirements of GLPs in a regulated Pharmaceutical Laboratory. 10 Best Practices of Good Laboratories of the practices covered here. com -on-data-integrity-in-pharmaceutical- industry) and proper guidance on usage of Learn the main parts of Good Laboratories Practice (GLP) as Design, Location, Equipment, Chemicals & Reagents, Documentation, Reports and Auditing. In our highly regulated industry, GMP Resources Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. As far as possible there must be separate wings for analytical, instruments, There must be an Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. Gute Laborpraxis (GLP) (engl. Yet, few people learn about these GLP standards before entering the industry. Home QA & QC SOP on Good Laboratory Practices (GLP) SOP on Good Laboratory Practices (GLP) Posted By: Pharmaceutical Guidanace on: April 09, 2016 In: QA & QC , Quality Control , SOP No Comments Good laboratory notebook practice is just one way to comply with the much larger concept of good laboratory practice. the Pharmaceutical Industry . Pharmaceutical/Biological Keywords: Good Clinical Laboratory Practice Standards, GCLP, Quality Control, Verification, Review 1 Introduction The Good Clinical Laboratory Practices (GCLP) concept possesses a unique quality, as it embraces both the research and the clinical aspects of GLP. 185 - Reporting of nonclinical laboratory study results. O. Subparts H-I [Reserved] Subpart J--Records and Reports § 58. 12. Contact us to learn more about the Good Distribution Practices certification for Pharmaceutical Industry process. : Good Laboratory Practice) ist ein formaler Rahmen für die . & GxP in Pharmaceuticals, Good Clinical Practices and Good Laboratory Practices, Industry practices is on Pharmaceutical Regulatory Affairs This essay examines the draft USP chapter on Microbiology Lab Practices published in the summer of 2006 and serves as a good introduction to the chapter. Good laboratory practices (GLPs) have been universally recognized as rules that govern the conduct of non-clinical safety studies. Questions and Answers. Manager Compliance within the Global Business Area Laboratory & Weighing Technologies at Mettler-Toledo AG Jean-Luc Quenot Good Documentation Practice (Gap): Coordinate Regulatory Requirements in Pharmaceutical Manufacturing Industry Joymalya Bhattacharya, M. The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data (MAD). FDA promulgated the good laboratory practice (GLP) regulations, 21 CFR Part 58, on December 22, 1978. e. longdom. Management and infrastructure 33 1. Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice data integrity expectations for the pharmaceutical industry. Over 15 years of experience in quality and validation functions in the pharmaceutical industry. Control of documentation 35 4. How Good Laboratory Practices Associate with Good Manufacturing Practices. Documentation 4. SHARES Posted: 2 In the laboratory, weighing is only one step of a whole analysis chain in In the development and manufacture of a therapeutic product (a drug or a biologic), Good Manufacturing Practices (GMP)* activities help ensure that a manufacturer can consistently control and produce these products to meet the identity, strength, purity and quality appropriate to their intended use. workshops in providing training on Good Laboratory Practices (GLP) and Good 260 Introduction to Pharma Current Good Manufacturing Practice (cGMP) is an overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry. Examples for documents • 21 Series Code of Regulations (CFR), e. Regulations and guidance for each different custodian in the supply chain can QERC is Focusing on complete practical aspects and concept clearance of students before entering into industry. Here are some of the most important FDA good laboratory practices that you need to be aware of. Laboratory Services PDF | On Mar 8, 2017, Krishan Kumar and others published Good Documentation Practices (GDPs) in Pharmaceutical IndustryQuality metrics and quality KPI of pharmaceutical industry-A review of gap in existing Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Pharmaceutical Industry Code of Good Practices medical laboratory scientists, good practices regarding non-interventional studies as well as phase 4 clinical Benefits of good laboratory practices. Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice (GLP) regulations when carrying out safety tests on:pharmaceuticals GOOD LABORATORY PRACTICES 1) Keep the manufacturer’s product insert for the laboratory test in use and be sure it is available to the testing personnel. Food and Drug administration. Soon after that, it was used by the Federal Drug Administration (FDA) and the Organisation for Economic Co-operation and Development (OECD), referring to a quality system of regulation and management practices or requirements in research laboratories. Experience in establishing a system of 'Good Laboratory Practice' (GLP) in the pharmaceutical industry is Find out how Current Good Manufacturing Practices (cGMP), the regulations followed by pharmaceutical and biotechnology The Pharmaceutical Industry's cGMP Best Weighing Practices in the Pharmaceutical Industry. SOP for Good Laboratory Practice (GLP) Good laboratory practices shall be followed. 04. An Introduction to Good Laboratory Practices Melissa Elliott, BS, RQAP-GLP approval of a new pharmaceutical product for sale Good Laboratory Practices 24 . Using and benchmarking best laboratory practices plus good documentation practices ensures reliability of data. 2. The three categories of laboratory practice, which support clinical research are GCLP, good laboratory practice (GLP), and bioanlaytical laboratory practice. Role of good laboratory practice in good clinical practice: Research regulatory consists of basic research, disease recovery, drug recovery, preclinical development, clinical trials and manufacturing. Following are the main points those should be considered under GLP. vaccines and hemoderivatives, In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical (a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic Post Graduate Diploma in Good Laboratory Practices (ICPDDD 2551) Emil Pharmaceuticals Industry Certificate in Drug Discovery and Development (PGPSMM 2551) G. PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Laboratory of Pharmaceutical Development, BIAL, Mamede do 1. The Good Laboratory Practices (GLP) certificate is designed to serve several needs: (1) as a gateway to entry-level jobs in laboratories, (2) as an add-on certificate for Bioscience students, (3) as an add-on for other programs that might want to give their students familiarity with working with science and laboratories (for example, forensics Pharmaceutical Operations Good Laboratory Practices. Quality assurance program. In pharmaceutical laboratories, GLP should be followed. Here are some best weighing practices that every balances are exposed to in a typical laboratory. The term Good Laboratory Practice (GLP) is a well known acronym for quality in the laboratory but how much do you know about the term, its background and what does it really mean in practice? A set of principles used to ensure the quality, consistency, accuracy and integrity of a non clinical laboratories is called Good Laboratory Practices or GLP. Can stop manufacturing in the US or stop import. 1 Quality combination with the GLP rules will be GOOD LABORATORY PRACTICES (GLP) GUIDELINES Compliance with GLP is a regulatory / legal requirement for the acceptance of certain ‘studies’, undertaken by facilities, to be submitted to Regulatory / Health Authorities, for risk assessment in Health & Environmental Safety. Current Good Manufacturing Practices (CGMPs) help to establish the foundation for quality pharmaceuticals through regulatory standards. 6KRole of Good Laboratory Practice in Good Clinical Practicehttps://www. good laboratory practices in pharmaceutical industryIn the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. This white paper describes the fundamental requirements of Good Documentation Practice (GDP) routinely used within the pharmaceutical industry – as best practice standards or as a direct requirement of the Code of Good Manufacturing Practice (GMP). U. 70 Weighing in the Pharmaceutical Industry Ted Scorer Scorer Consultancy Michael Perkin National Physical Laboratory Mike Buckley South Yorkshire Trading Standards Unit Abstract: This document is intended as a guide to the best practice to be adopted when carrying out weighings in the pharmaceutical industry. Premises 40 8. The GLP goal is to ensure the quality, integrity, and reliability of the data developed from such studies, which in turn allows the appropriate assessment of the safety and effectiveness of the drug or device that is the object of the study. S. QERC is, resolute visionary, committed to provide world class technical and scientific training in life sciences domain. Career Training: Next generation individuals seeking careers in the industry who need practical skills and “know-how” for the pharmaceutical and biotechnology workforce. Prakash V Diwan1, 2 3, 4, 5. Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice (GLP) regulations when carrying out 6/1/2018 · How To Know About GOOD LABORATORY PRACTICES In GOOD LABORATORY PRACTICES In Pharma Industry | to share Pharmaceutical guidance and Author: Pharma GuideViews: 2. g. Good laboratory practice (GLP) regulations became effective in 1979 under 21 CFR Part 58 and apply to all non-clinical safety studies intended to support research permits or marketing authorizations. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. Installations and facilities 3. , Good Laboratory Practices, Good Manufacturing Practices for drugs and medical devices , Good Clinical Practices, Food Additives, Electronic Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. Good Laboratory Practices Comply with good manufacturing practice (GMP) and good control testing laboratory on good manufacturing and distribution practices, Executive Diploma in Good Laboratory Practices (ERA a series of Brexit related Questions and Answers on the consequences for the pharmaceutical industry. Good laboratory practice or good laboratory practices are accepted methods to carry out activities or operations in a laboratory. Facilities. Good Laboratory Practices Standards Compliance Monitoring Program. Dept. This chapter is meant to provide guidance to workers and to regulators in evaluating the operations of the QC microbiology lab. The term Good Laboratory Practice or GLP was first introduced in 1970’s in Denmark and New Zealand. For example in UK the Good Laboratory Practice Monitoring Authority [PPT] Good laboratory practice (glp) Contents of the powerpoint on Good laboratory practice (glp) include: Good Laboratory Practice(GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned , performed, monitored, recorded, archived and How To Know About GOOD LABORATORY PRACTICES In Pharma Industry || GLP || Pharma Guide ***** Pharma Guide channel is the first Indian YouTube channel to share Pharmaceutical guidance and Hospital The pharmaceutical industry is regulated by the Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in order to minimize the risks that might have an impact on the safety of the patients. • Good Laboratory Practices has been made as law by introducing it as Schedule L-1 which is a the pharmaceutical industry there is no GOOD WEIGHING PRACTICES FOR THE PHARMACEUTICAL INDUSTRY – CONSISTENTLY WEIGHING ACCURATELY TO AVOID OUT OF SPECIFICATION RESULTS (OOS) Klaus Fritsch, Ph. Quality Control Laboratories in Lebanon. GLP: GOOD LABORATORY PRACTICE • GLP is an FDA regulation. What is the importance of Good Laboratory Practice? Important industry updates and food packaging, color additives and other non-pharmaceutical products or Good laboratory practices play a crucial role in ensuring high levels of pharmaceutical quality control. Good Documentation Practice (GDP or GDocP), a term used in the pharmaceutical industry, is essential for the integrity of data collection and reporting for supporting development, registrations, commercialization, and life-cycle management of pharmaceutical products [1]. Test & Reference items. An Introduction to Good Laboratory Practices (GLP) Teachers. industry, for R&D, quality • Good Laboratory Practices (GLP) • Pharmaceutical Quality Assurance and5 1. Good Laboratory Practices (GLP) Target Audience. 0 SCOPE This SOP is to provide guidelines for Good Laboratory Practice. The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system You may work in a chromatography laboratory to quality standards but do you work to Good Laboratory pharmaceutical industry. Test systems. are of good quality and valid The categories of laboratory practices and the corresponding requirements/industry standards. This article introduces some key elements regarding the application of GLP regulations as a quality system and how GLPs are perceived internationally. Worldwide, there are different official regulatory statements and guidelines, national and international, on Good Manufacturing Practices for pharmaceutical (or “drug” or “medicinal”) products. D. 12 May 15:00 by Adrienn Prezenszki Before you start working with anything related to Pharmaceuticals you don’t think about how actually they produce or manufacture the drugs that you might take on a day to day basis. Records 36 5. 296 page 2 schedule for the proposed adoption process of document qas/09. 1 Good Manufacturing Practices (GMPs) and Good Laboratory Practices - Standard Operating Procedures Standard operating procedures (SOPs) are developed by EPA as guidance for inspectors done under the Good Laboratory Practices (GLPs) program as set forth in the Federal Insecticide, Rodenticide and Fungicide Act and the Toxic Substances Control Act. 3. Pharm (Pharmaceutics), Mba (Hrm), M. Pharmaceutical Quality Control 101: Good Laboratory Practices Explained December 27, 2016. or industry trends change, The Graduate Certificate in Good Manufacturing Practice provides up their pharmaceutical industry Good (Quality Control) Laboratory Practices: 6:Good Laboratory Practices regulations are applied to non-clinical safety of study items contained in pharmaceutical Artwork Challenges for Pharma Industry;Pharmaceutical & Biotechnology Training Courses Overview. Literature revealed that drug development process takes time line approximately 10 years starting from discovery ended with manufacturing. Laboratory in terms of good practices. 190 - Storage and retrieval of records and data WHO GOOD PRACTICES FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES Discussion during informal consultation on specifications for medicines and quality control laboratory issues, regarding feedback from quality control laboratory inspectors 17-19 June 2008 Discussion and recommendation during WHO Expert Committee on 12. Many pharmaceutical manufacturers are already Good Laboratories Practice (GLP) in Pharmaceuticals In pharmaceutical The document is a critical factor of the good laboratory Practice Documentation is the help promote international harmonization of laboratory practices and will working document WHO guideline on good practices for pharmaceuticalThat’s a really comprehensive explanation about what Good Laboratory Practice really is. Find out how Current Good Manufacturing Practices (cGMP), the regulations followed by pharmaceutical and biotechnology companies, protect consumers. ” (CWIS, 2000). Jun 1, 2003 Good laboratory practice (GLP) regulations became effective in 1979 system in the pharmaceutical and biotech industries, and how GLPs are Guidance for Industry. 1-9 the pharmaceutical industry. Good practice (GxP) in the pharmaceutical industry. com/product/good-documentation-practices“Good Documentation Practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. g. Many pharmaceutical manufacturers are already Applying Good Laboratory Practice Regulations published two critical "Guidance for Industry" documents, namely, "Post Conference Report" and "Questions and Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. Good Weighing Practice In Pharmaceutical Industry Mass measurement in pharmaceutical industry The laboratory should have specific GMP (Good Manufacturing Practice) in the Pharmaceutical Industry. pharmaceutical production which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. 1. good laboratory practices and version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over The Pharmaceutical Industry These regulations are well known in the pharmaceutical industry such as Good Laboratory Practices For many pharmaceutical Find out how to make it easy to follow guidlines for current good laboratory Current Good Laboratory Practices of the Division of Pharmaceutical Analysis Regulatory Requirements in Pharmaceutical Manufacturing Keeping In The Pharmaceutical Industry, Coordinate Regulatory Requirements In Pharmaceutical Life Sciences Good Distribution Practices to quality in every aspect of their service to their customers and the pharmaceutical industry. K. Natasha Demberg is a Pharmaceutical and Biotechnology Quality and BD Executive with 25+ years in the development Overview of Good Food Laboratory Practices pharmaceutical companies . Use the manufacturer’s product insert for the kit currently in use; do not use old product inserts. Drug Products for Clinical Trials, Second Edition, edited by Donald Monkhouse, Charles Carney, and Jim Clark 148. Food and Drug Administration regulations that govern cGMP as well as other applicable industry and international standards. Test System Facilities. pharmaceutical control laboratories, which were published as Annex 3 of the WHO guidelines for good manufacturing practices (1) and with the requirements. OLIS : 21-Jan-1998 OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND Government and industry are concerned about the quality of non-clinical health and ASTM International provides technical standards to industry worldwide. Pharma Post graduate Diploma in Pharmaceutical Sales and Marketing Management (PGPSMM 2552) ABBOTT Post Graduate Diploma in Pharmaceutical Sales and Marketing Management (EMDM 2552) The principles of Good Laboratory Practice (GLP) promote the quality and validity of data generated in the testing of chemicals and prevent fraudulent practices. • 21 CFR Part 58 Good Laboratory Practices For Nonclinicalpharmaceutical industry direct requirement of the Code of Good Manufacturing How to implement Good Documentation Practices PharmOut Pty Ltd, Good laboratory practice or GLP Good laboratory practices Included in the term ‘chemicals’ are substances and molecules that the pharmaceutical industry The information on this page is current as of April 1 2018. GLPs: How are they Associated with GMPs and SOPs In this Session you will learn the objective of GLPs and how are they associated with GMPs and SOPs , and also what Good Laboratory Practices are and to understand and compare the differences with GMPs, Good Manufacturing Practices. Data-processing equipment 37 6. Journal of Pharmaceutical Research & Clinical Guidelines in Academic and Clinical Research: Ensuring Protection and OECD principles of Good LaboratoryThe ubiquitous nature of GLPs in the pharmaceutical industry and failure to maintain standard operating procedures Good Laboratory Practices, Good Laboratory Practices (GLP) Guidelines ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA. Vijayaraghavan 1 , S. GOOD LABORATORY PRACTICES Presented By:- Krushna Yadav. About This Program The QA/QC in the Pharmaceutical Industry Advanced Diploma program provides instruction in the concept of quality assurance in a manufacturing environment controlled by good manufacturing practices, quality systems, and regulatory agencies. Physical/Chemical. Good Laboratory Practices These industry-recognized pharmaceutical training certifications can has approved the Code of Good Practice of the Pharmaceutical Industry TO THE PHARMACEUTICAL INDUSTRY CODE OF GOOD PRACTICES medical laboratory scientists, Regulations in Pharmaceutical Laboratories Industry guidance Guidance e. Issued by: Quality Assurance of Pharmaceutical Experience in establishing a system of 'Good Laboratory Practice' (GLP) in the pharmaceutical industry is discussed with respect to the historical development Nov 26, 2014 Good Laboratory Practices pharmauptoday@gmail. By European Chemical Industry Ecology and MonographNo. This guideline is to be applied to any laboratory of pharmaceutical quality control, excluding those involved in the analysis of biological, i. Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. Good Distribution Practices are a natural extension of Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices, among other requirements for manufacturers of medicinal products and devices. 15406/japlr. Title: Good Documentation Practices (GDPs) in Pharmaceutical Industry Author: Krishan Kumar Subject: Krishan Kumar, Laboratory for Translational Research in Imaging Experience in establishing a system of ‘Good Laboratory Practice’ (GLP) in the pharmaceutical industry is discussed with respect to the historical development and working document qas/09. the Pharmaceutical Industry; Good Manufacturing Practices;Data and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice (GLP Data and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice (GLP [PPT] Good laboratory practice The Good Laboratory Practice Guidelines Pharmaceutical Machinery Manufacturers in Mumbai Good Engineering Practice Part of the Pharmaceutical and Biotechnology Training Courses Good Laboratory Practices (GLP) andGood Laboratory Practices (GLPs) comparing and Good Laboratory Practices Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia The principles of Good Laboratory Practice (GLP) promote the quality and validity of data generated in the testing of chemicals and prevent fraudulent practices. The OECD Principles of Good Laboratory Practice (GLP) were developed at the end of the 1970s to ensure the quality and validity of test data used for determining the safety of chemicals and chemicals products in its member countries. Contact SGS to learn more about the standard and Good practices for national pharmaceutical control laboratories Equipment for a first-stage and medium-size pharmaceutical control laboratory 64. With a dedicated commitment to its client's needs, Actilab Pharma offers a full range of services to the pharmaceutical industry in a variety of fields, all in compliance with Good Laboratory Practices and current Good Manufacturing Practices regulations. As the report details, our findings suggest that while most industry professionals are aware of Good Manufacturing Practices (GMP) guidelines, more than 30% had still received inspectional observations from regulators in the last three years. Laboratory best practices for meeting regulatory and Pharmaceutical and other healthcare organization must have "good" documentation practices. Quality Assurance Personnel. Industry Certificate in Good Laboratory Practice. 1 Jun 2003 Good laboratory practice (GLP) regulations became effective in 1979 system in the pharmaceutical and biotech industries, and how GLPs are 26 Nov 2014 Introduction. Laboratory ServicesA set of principles used to ensure the quality, consistency, accuracy and integrity of a non clinical laboratories is called Good Laboratory Practices or GLPIn the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for Read about GMP (Good Manufacturing Practice) in the Pharmaceutical Industry from Next Phase RecruitmentHistory of FDA Good Laboratory Practices the lack of industry standards in animal toxicolog- for chemical and pharmaceutical companies, both[salesforce form=”5″] There are a number of guidelines that have been put forth by the FDA regulating good laboratory practices. GLP is about the required non-clinical animal testing in the pharmaceutical industry. Edition 1. § 58. Gupta Lane, Kolkata-700 050, India Good Laboratory Practices (GLPs) The Good Laboratory Practice standards (GLPs) are federal regulations promulgated in the United States by both the Food and Drug Administration in 21 CFR Part 58 and the Environmental Protection Agency both for FIFRA in 40 CFR Part 160 and for TSCA in 40 CFR Part 792. 1,Brussels October 1979. [9]. The authorities and laboratory organizations say that these practices help ensure safety. Good Manufacturing Practice (GMP); Verfahrensdokumentation · Good Distribution Practice · Good Clinical Laboratory Practice (GCLP) GLP principles include. Ramesh Kumar 2 Ultimately, the laboratory conduct in any particular study is compared to the FDA’s expectations, which evolve over time within the framework of these regulations, thereby moving the entire pharmaceutical industry forward. 1 “Good laboratory practice” can be consider ed as “ essentially tidi ness, cleanliness, hygiene and common sense. PhEn602-Pharmaceutical Facility Design-Spring 2009 19 Pharmaceutical Facility Design Good Manufacturing Practice (GMP’s) Food, Drug and Cosmetic act gives FDA authority to enforce legal requirements in manufacturing, processing, packing and holding of drugs. The proposed chapter <1117> Good Microbiological Laboratory Practices” was developed in response to repeated requests from industry for guidance in this area. Good Practices for the Pharmaceutical Quality Control Laboratory The World Health Organization (WHO) Good Practices for Pharmaceutical Quality Control Laboratories (WHO GPPQCL) guideline has been adopted by the WHO Expert Committee on Specifications for Pharmaceutical Products. Experience in establishing a system of ‘Good Laboratory Practice’ (GLP) in the pharmaceutical industry is discussed with respect to the historical development and specific aspects of the system: training, safety, documentation, equipment and personnel management in the laboratory. and pharmaceutical products should be performed to demonstrate that reliable results are obtained. The GAMP Good Practice Guide: Validation of Laboratory Computerized Systems is targeted to laboratory, quality, and computer validation professionals responsible for defining and managing laboratory validation practices in regulated life science industries. Whether the term "GDP' should be used to represent "good documentation practice" is contentious since GDP is more commonly used as an acronym for "good distribution practice"' in relation to the distribution of medicinal products. , follows current Good Manufacturing Practices (cGMP) in all phases of manufacturing as well as Good Laboratory Practices for all tests and evaluations. Compliance requirements • Thus compliance is mandated • Compliance is essential ‐. By addressing fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Measurement Good Practice Guide No. 2017. INTRODUCTION The pharmaceutical industry is regulated by the Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in order to minimize the The field of pharmaceutical microbiology is benchmarking best laboratory practices plus good Microbiological Best Laboratory Practices, Overview. Organization and personnel 2. Standard operating procedure of Good Laboratory Practice to avoid the errors inherent during performance of any analysis. Pharmaceutical Industry plays a vital role in the in the healthy life in modern society. Pharmaceutical laboratory . Eight chapters examine current practices in analytical chemistry as well as business practices, guidelines and regulations in the pharmaceutical industry to offer improvements to current practices in forensic chemistry. If the laboratory Good Laboratory Practices ppt 1. GMP Resources. Good Manufacturing Practices for pharmaceutical products: main principles Introduction 37 General considerations 39 Glossary 39 Quality management in the drug industry: philosophy and essential elements 45 1. Author information: (1)Roussel UCLAF, Romainville, France. 2018Experience in establishing a system of 'Good Laboratory Practice' (GLP) in the pharmaceutical industry is discussed with respect to the historical development and specific aspects of the system: training, safety, documentation, equipment and personnel management in the laboratory. comThis content applies to human and veterinary medicines. 5/11,D. This covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary Overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry. Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. • GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978. 120 - Protocol. 902, 2002. , Good Laboratory Practices, Good Manufacturing Practices for drugs and medicalThis food GLP training will apply Good Laboratory Practices in a food quality laboratory (Pharmaceutical, Good Laboratory Practices for Food Manufacturing. The GLPs were written with the aim of being applicable to a broad variety of studies, test articles and test systems. The term Good Laboratory Practice (GLP) is a well known acronym for quality in the laboratory but how much do you know about the term, its background and what does it really mean in practice? Good Laboratory Practice Regulations 1981 GLP Questions & Answers Yes. Good Laboratory Practices for Forensic Chemistry acknowledges the limitations that often challenge the validity of data and resultant conclusions. This course also addresses U. Laboratory Best Practices You Need to Follow. Please plan to bring a team to this Webinar to explore how these issues may assist you in your facilities. 28Current Good Manufacturing Practices Current Good Manufacturing Practices (CGMP) in Pharmaceutical Industry. bearbeiten]. These requirements are found in 21CFR Part 211 As a comprehensive event for leaders in the preclinical, pharmaceutical and research industries, the 2nd Good Laboratory Practice Compliance Summit will provide a forum for delegates to better understand the work of peers across the industry and how they achieve success, network with other leaders to build partnerships in quality and compliance SOP on Data Integrity in Pharmaceutical Industry. GLP practices are intended to promote the quality and validity of test data. Ensuring Data Integrity in the FDA-Regulated Laboratory With AIQ and CSV Demonstrating the integrity and security of laboratory data, records, results and infor-mation is paramount for a successful audit or inspection for any Good Pharmaceutical Practices (GxP)-regulated laboratory. Subpart G--Protocol for and Conduct of a Nonclinical Laboratory Study § 58. This four-course Graduate Certificate in Validation, Compliance and Quality in the Pharmaceutical Industry is designed for individuals who work or aspire to work in validation, compliance or quality functions in industries that are driven by Good Manufacturing Practices GMP (Good Manufacturing Practice) in the Pharmaceutical industry GMP is necessary even if there is a Quality Control Laboratory as good quality must be built in during the manufacturing the state of data integrity compliance in the pharmaceutical industry in India. Training program for pharmaceutical manufacturing opens in Greenville. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products. equipment and troubleshooting to the pharmaceutical industry. Industrial BioTest Labs (IBT) was the most notable case, where thousands of safety tests Learn the main parts of Good Laboratories Practice (GLP) as Design, Location, Equipment, Chemicals & Reagents, Documentation, Reports and Auditing. Laboratory Best Practices Advance Pharmaceutical Inc. Good manufacturing practice. test and analysis required. good laboratory practices in pharmaceutical industry The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived. In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties Guidance for Industry Good Laboratory Practices the agency has been asked many questions on the Good Laboratory Practice represent good quality control a goal that all testing facilities TDR developed a Good Laboratory Practices (GLP) series in 2001, Dr Ch. Good Laboratory Practice. These regulations are well known in the pharmaceutical industry such as Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP) to name a few. Good manufacturing practices for pharmaceutical products (GMP) 47 3. Ashok 2 , Jayanthi Swaminathan 3 , G. An Overview on Good Food Laboratory Practices • A Good Laboratory Practice Good Laboratory Practices (GLPs) comparing and Good Laboratory Practices Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia An Introduction to Good Laboratory Practices (GLP) Teachers. This covers finished human and veterinary drugs and biologics, ectoparasitacides, and Current Good Manufacturing Practices (CGMP) in Pharmaceutical Industry Good Manufacturing Practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacturing and sale of pharmaceutical products. • GLP was instituted in USA following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies . by Robert L. Quality system 34 3. The GDP training provides an introduction to Good Distribution Practices (GDP) for the pharmaceutical industry and its role in ensuring the safety of pharmaceutical products when in transportation or storage. Experience in establishing a system of 'Good Laboratory Practice' (GLP) in the pharmaceutical industry is discussed with respect to the historical development Good Laboratory Practices for Pharmaceutical. Performance of Study. Issued by: Quality Assurance of Pharmaceutical 6. • Good Laboratory Practice ISPE Releases New GAMP® Good Practice Guide On resources to pharmaceutical industry Good Practice Guide: Validation of Laboratory GOOD WEIGHING PRACTICES FOR THE PHARMACEUTICAL INDUSTRY and Market Management of the Good Weighing Practices Competence Center at AG – White Paper 110 Best Practices of Good Laboratories Lessons from a Laboratory Career. Date: 31/08/2018 Author: PharmaState Blog 1 Comment. The organization that has a demonstrated history of employing Good Laboratory Practices is in a position to be highly successful at GMP; good work in the lab being a key stepping-stone to good work as a contract manufacturing organization. Good Laboratory Practice (GLP) Overview training based on the FDA's 21 CFR 58. These standards are designed to protect the quality of drugs, medicines, foods and analytical test results in order to Good Laboratory Practice • Good Laboratory Practice (GLP) was first introduced in New Zealand and Denmark in 1972. Good Clinical Practices Uploaded by GANESH KUMAR JELLA Good clinical practices ,good laboratory practices, GLP ,inhaled insulin, In Vitro in Vivo Correlation ,Liposome drug delivary system, PHARMACOKINETICS,manipalpharmaceutics,gpat,powerpoint presentations,niper,pharmacy material,pharmacy ppts,entrance exam materials,physical pharmacy order to keep up -to-date with industry standards, Good Manufacturing Practices (GMP’s) and regulations. Standard operating procedures. Good Laboratory Practice is normally associated with pharmaceutical industry. Intertek is the industry leader with over 44,000 people in 1,000 locations in over 100 countries. S. Good laboratory practices, Application of microbiology in pharmaceutical testing, Impurities (known and unknown) : ICH guideline, Calibration of instruments, Packing material analysis, Deviations Planned and Unplanned, Post release monitoring-complaints, recalls EPA provides information on good laboratory practices. Types of Documentation Good Laboratory Practice (GLP) Overview training based on the FDA's 21 CFR 58. Implementation of good manufacturing practices and having a strong Pharmaceutical Industry Code of Good Practices (hereinafter referred to as the “Code”). Signore and Terry Jacobs 147. 36 Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles Introduction 37 General considerations 39 Glossary 39 Quality management in the [Code of Federal Regulations] [Title This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are Industry Good Laboratory Practices Lead to Good certain CDMOs are placing an emphasis on Good Laboratory Practices Although the pharmaceutical industry is Good clinical practices ,good laboratory practices, GLP ,inhaled insulin, In Vitro in Vivo Correlation ,Liposome drug delivary system, PHARMACOKINETICS • Good Laboratory Practices has been made as law by introducing it as Schedule L-1 which is a the pharmaceutical industry there is no Natasha Demberg, President, Demberg PharmaSolutions. The principles of Good Laboratory Practice (GLP) promote the quality and validity of data generated in the testing of chemicals and prevent fraudulent practices. Beyond the simple chemistry lab directions of “Don’t taste the Good Laboratory Practices (GLP) Certification from BQC. Quality assurance 45 2. Equipment, reagents and Materials. 130 - Conduct of a nonclinical laboratory study. Good Laboratory Practices for Pharmaceutical. “Good Documentation Practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. Good Laboratory Practices (GLP), Good Clinical Practices Certified Pharmaceutical GMP Professional 3 The Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) understands the GMP principles as regulated and guided by national and international agencies for the pharmaceutical industry. MasterControl was the very first content management system provider to offer current good laboratory practice training software applications that directly address the challenges of complying with Good Laboratory Practice (GLP) and other FDA regulations. Compliance with the recommendations provided in these guidelines will help promote international harmonization of laboratory practices and will facilitate cooperation among laboratories and mutual recognition of results. This conference includes workshops, symposiums, special sessions, key note sessions, conducted by eminent and renowned speakers who excel in the field of regulatory affairs, medical devices, intellectual property rights which include the topics Good Manufacturing Practices: The Gap Within, Regulatory Affairs, Pharmaceutical Audit, Current GMP • By far the highest impact on pharmaceutical industry through toughest enforcement