Auditing the QC Microbiology Laboratory for FDA Compliance

Why Should You Attend:

Microbiology analytic testing is designed for the detection of pathogenic and non-pathogenic microorganisms that are prevalent in materials subject to human and animal exposure, and in the environment. In order to ensure safety and hygiene the testing procedures and the laboratories where they are performed are impacted by defined regulatory guidelines at non-clinical testing and manufacturing facilities.

An important aspect of compliance includes periodic internal and external inspections to ensure the enforcement of quality policies. These regulatory requirements broadly comprise management systems that enforce rules and monitors standard operating procedures, methods validation, organizational structure, qualifications and training of personnel, facilities, biosafety precautions, equipment validation and performance, reagent certification, document control including the recording, reporting, and archiving of information, and laboratory information management systems (LIMS). Preparation for inspections is a fundamental aspect of routine operations.

This webinar based on FDA guidelines will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures, resolution of audit findings, and examples of issuance of 483s and warning letters.

This webinar will be a comprehensive overview of Auditing of a Microbiology Laboratory for QC compliance.

• The following topics will be addressed:
  • Infrastructure of a Microbiology Testing Laboratory.
  • Test Methods and Validation.
  • Equipment.
  • Documentation.
  • Preparation for inspections.
  • Corrective Actions.
  • Preventive Actions.

Who Will Benefit:

This webinar is highly recommended for personnel in microbiology testing laboratories at contract research organizations, the medical device, pharmaceutical and biotechnology industry. The material will be beneficial for beginners, and also serve as a refresher for experienced professionals.

Areas of Relevance include:

• R&D
• Regulatory Affairs
• Quality Control and Quality Assurance
• Manufacturing

The employees that this information would be pertinent include:

• Microbiology Analysts
• Laboratory Supervisors and Directors, Managers
• QC Auditors and Inspectors
• Microbiological testing analysts
• Regulatory Affairs
• Quality Control and Quality Assurance
• Training
• Consultants
• Auditors and Inspectors

Instructor Profile:

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 regulatory approval. 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. Consulting projects have included strategic product development plans, pre-clinical proof of concept studies, due diligence and audits of CROs, and grant and technical report writing.

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.

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