This course is designed particularly for the laboratory scientist to provide an appreciation of the regulated environment in which clinical studies are conducted and its relevance when collecting and analyzing biological specimens during a study. The drug development process (discovery through post-market) will be reviewed with particular attention to the fundamentals of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and where/how they apply. Examples and the impact of non-compliance will be discussed. Review and reinforcement of important concepts, such as laboratory accreditation, will be achieved through discussion and examples. The role of quality management in GCP Laboratories will be evaluated along with the standards to have in place that will ensure compliance, including outsourcing clinical laboratory activities. The challenges when conducting global studies related to specimen collection will also be discussed.

• Review the drug development process from discovery through post-market
• Describe the regulated environment in which clinical studies are conducted, including the handling/analyzing of biological specimens
• Discuss the fundamentals of GLP, GCP and GMP and where/how they apply
• Examine examples and impact of non-compliance with GLP/GCP
• Describe the role of quality management in GCP laboratories and the standards to have in place that will ensure compliance
• Discuss outsourcing clinical laboratory activities to minimize compliance risks
• Identify the role of laboratory accreditation in clinical studies
• Discuss the additional challenges related to specimen collection when conducting global studies

• Laboratory scientists
• Research assistants
• Laboratory supervisors
• Principal scientists
• Research personnel that write protocols and/or handle/analyze biological specimens collected during a clinical study (analysis for drug metabolites, biomarkers, investigational products)

Gary B. Freeman, M.S., C.C.R.A.

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Day 1: 8:30 a.m. – 5:00 p.m.

• Overview of the drug development process: Discovery through post-market
• Working in a regulated environment: Definitions of GLP, GCP, and GMP; Global regulatory authorities – mission and responsibilities; Regulations – US (Code of Federal Regulation); ex-US (International Conference on Harmonization – ICH GCP E6; EU Directive); forgotten elements
• Fundamentals of GLP, GCP and GMP: Non-clinical testing (GLP) – elements and examples of non-compliance; Clinical research (GCP) – elements, sponsor responsibilities, examples of non-compliance; Investigational product manufacture (GMP) – elements and examples of non-compliance
• Quality Management of GCP Laboratories: Laboratory Quality System identification, Qualifications, Outsourcing, Accreditation, Challenges with global studies

• Situational reviews of practical scenarios
• Critique of current FDA Warning Letters
• Group discussions

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-14-051-L01-P. Released 9/14.

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For more information, contact Naila Ganatra at (215) 413-2471.