The design and establishment of the laboratory facility, test methods and materials handling are impacted by stringent guidelines defined by regulatory agencies including the Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and represented as Good Laboratory Practice (GLP) regulations delineated in 21 CFR Part 58. An additional component of a preclinical development program is the necessity of periodic internal and external audits of the facilities to ascertain the enforcement and consequent adherence of quality policies. The management systems that are encompassed by regulatory scrutiny include but are not limited to GLP practices and technique, bio-safety handling practices, standard operating procedural compliance, methods validation, organizational structure, training, proficiency assessment and qualifications of personnel, reagent certification, document control involving the recording, reporting and archiving of information, and laboratory management systems. 

This interactive course will provide comprehensive guidelines and strategies for conducting and managing a preclinical development program for biologic candidates eventually leading to IND studies. The guidelines will be in accordance with current global regulatory (FDA, ICH) directives, and the management of these mandates will ensure successful audits for compliance, and submissions. Target areas for potential compliance infractions, resolution of audit findings, and pertinent case studies regarding the issuance of 483s and warning letters will be discussed.

The GLP compliance regulations discussed in this course will be applicable to biologics, pharmaceuticals and medical devices.

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

Chitra Edwin, Ph.D., RAC. has significant 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 a key member in the development of products for AIDS and cancer that have obtained FDA approval and are commercially available. She has successfully established and managed GLP and CLIA compliant laboratories, managed multidisciplinary project teams, executed technology transfers, and orchestrated collaborations between national and international professionals. Dr. Edwin’s responsibilities have included the pre-clinical development 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 the bioscience industry. Dr. Edwin has held management positions at Chiron Corporation (currently Novartis) and MassBiologics (formerly the Massachusetts Biologic Laboratories). Dr. Edwin is an Adjunct Associate Professor of Pharmaceutical Sciences, Director of the Capstone project, College of Pharmacy, University of Cincinnati where she teaches regulatory compliance and pharmaceutical product development, and mentors students in the Master’s in Drug Development program. She offered a training course in GMP as part of the Global Training Network, WHO Department of Vaccines and Biologicals, and frequently conducts webinars on product development and regulatory compliance for reputed e-learning companies. Dr. Edwin has been a consultant for the biotechnology, and diagnostics industry since 2005, and founded Biotechnology Consulting Solutions, Ltd. in 2006.

Dr. Edwin obtained her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota, followed by post-doctoral training in Infectious Diseases at the Harvard Medical School and the Dana Farber Cancer Institute. She has secured Regulatory Affairs board certification (RAC). She is a Review Board member of Opus Institutional Review Board (IRB). She was a co-founder and President of the Graduate Women in Science (Massachusetts chapter). Memberships have been held in Sigma Xi; Scientific Research Society, ASM, AAAS, RAPS, MIT Forum, GWIS, the Foreign Policy Leadership Council of Greater Cincinnati, BioOhio and Kindervelt.

Topic Background:

The basic premise of Good Laboratory Practice (GLP) is to monitor universities, contract laboratories and biopharmaceutical companies that conduct animal and clinical studies to ensure the quality and authenticity of drug safety information. These GLP requirements were established by regulatory authorities in the 1970s following inspections of institutions that revealed appalling animal testing conditions and deceptive data reports submitted for FDA approval. Preclinical testing for the assessment of efficacy and safety of biologic therapeutics, and the performance of medical devices is an integral component of product development. A majority of preclinical studies are impacted by stringent GLP regulations if they are components of efficacy and safety informational packages seeking FDA approval for marketing permits. In addition, these studies are essential precursors for the identification of effective dosage levels, key pharmacokinetic efficacy and safety parameters, and specification limits prior to embarking on human clinical trials. The evaluations are performed in vitro systems and in vivo animal models following optimized, approved standard operating procedures. These protocols are specific for the physiochemical qualification and mechanism of action of the drug candidate.