cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products

Why Should You Attend:
cGMP guide lines were formulated for the purpose of regulating large-scale manufacturing and commercial drug products. But it is amended in 21 CFR Part 210 for applicability to small-scale laboratory production of exploratory and investigational drug and biologic products. The amended GMP guide lines are a component of the FDA’s “Product Quality for the 21st Century” initiative for a selective approach to varying production objectives during drug development. These exemptions allow the option to the FDA to advise investigators on the safety requirements of laboratory production lots that unequivocally permit administration to human subjects in clinical trials.

This webinar will provide a detailed overview of cGMP regulations for IND drug and biologic products. The applicable requirements from earlier FDA guidance documents will also be addressed. The key differences between cGMP regulations between IND and manufacturing production will be identified to enable streamlining the drug development process through the identification of new, innovative therapies. The comprehensive guidelines of regulatory agencies including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.

In conclusion, this webinar will educate the participant on the broad ranging systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates, risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.

• Key aspects of FDA cGMP requirements for IND products.
• Historical FDA cGMP requirements for drugs and biologics.
• Practical implications.
• Regulatory guidelines; FDA, ICH, CHMP, EMEA.

• Executive management
• R&D investigators
• Product development
• Pre-clinical and clinical
• Regulatory affairs
• QA/ QC
• Marketing
• Consultants
• Training

Instructor Profile:
Chitra Edwin, Ph.D., RAC., Principal, Biotechnology Consulting Solutions, Ltd. has over 15 years of product development and management experience in start-ups, mid-sized and large biotechnology and diagnostic companies. She has managed projects from concept, R&D through manufacturing transfer, and has been involved in the development of approved products. She has successfully established regulatory compliant laboratories, managed multidisciplinary project teams, executed technology transfers, and orchestrated collaborations between national and international professionals. Dr. Edwin’s responsibilities have included pre-clinical evaluations of therapeutic biologics, vaccines and diagnostics. She has functioned as a facilitator between academia and industry that culminated in contractual service agreements, and organized professional meetings with representatives from academia and industry.

Dr. Edwin has provided Life Sciences consulting services to start-ups, Fortune 500 and healthcare consulting companies focused in biologics, diagnostics and devices. Client assistance was provided in product development, technology assessment/ technology transfer, due diligence, pre-clinical testing, proof of concept studies, regulatory affairs/ regulatory strategy, project management, SBIR grants, technical/ medical reports and scientific reviews. These assignments have also included audits of Contract Research Organizations. Dr. Edwin also conducts regulatory compliance training courses and webinars.

Dr. Edwin obtained her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota followed by post-doctoral training at the Harvard Medical School and the Dana Farber Cancer Institute. She has obtained Regulatory Affairs board certification (RAC). Dr. Edwin is an Adjunct Associate Professor of Pharmaceutical Sciences, Director of the Capstone project, College of Pharmacy; University of Cincinnati where she teaches for the Master’s in Drug Development program.

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