Strategies to establish and manage a compliant contemporary microbiology laboratory

Why should you Attend:
An element of risk is prevalent in a microbiological testing environment due to safety hazards posed not only by potential infectious testing materials, but also by the chemicals and radio-isotopic reagents required for the analysis of these samples. A key requirement of a microbiology laboratory is the execution of specialized safety practices, and containment measures to minimize or ideally eliminate the exposure of hazardous agents to laboratory personnel directly involved in laboratory operations.

The design and establishment of a testing facility 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 Centers for Disease Control (CDC). In addition, periodic internal and external monitoring of the facilities is necessitated to ensure the enforcement and continuity of quality policies. The management systems impacted for regulatory scrutiny broadly comprise good laboratory practices and technique, bio-safety handling practices, standard operating procedures, methods validation, organizational structure, qualifications and training of personnel, safety equipment validation and performance, reagent certification, document control including the recording, reporting, and archiving of information, and laboratory information management systems (LIMS).

This webinar will provide comprehensive strategies for the design of a microbiology testing laboratory in accordance with current global regulatory (FDA, ICH and CDC) directives, and the management of these mandates to ensure successful audits for quality compliance and biological hazard protection. Target areas for potential compliance failures, and relevant case studies will also be addressed.

Areas Covered in the seminar:

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

• The following topics will be addressed:.
  • Design of a Microbiology Testing Laboratory.
  • Biosafety Levels.
  • Laboratory practices and safety.
  • Safety Equipment.
  • Documentation.
  • Inspections.
  • Corrective and Preventive Actions.

Who Will Benefit:
This webinar is highly recommended for personnel in microbiology testing laboratories at contract research organizations, biotechnology, pharmaceutical and device industry. The material will be beneficial for professionals with microbiology training and experience. 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

Instructor Profile:
Chitra Edwin, Ph.D., the founder of 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 commercial products for AIDS and cancer. She has successfully established fully functional GLP and CLIA compliant laboratories, managed multidisciplinary project teams, executed technology transfers, and orchestrated collaborations between national and international professionals.

Dr. Edwin has managed pre-clinical evaluations of potential therapeutic biologics and vaccines. 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 consulting services to start-ups, Fortune 500 and healthcare consulting companies focused in biologics and devices. Consulting services have been provided in areas of product development, technology assessment/ technology transfer, due diligence, pre-clinical testing, proof of concept studies, regulatory affairs/ regulatory strategy, project management, and the preparation of SBIR grants, technical/ medical reports and scientific reviews.

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) from the Regulatory Affairs Professional Society. She is an Adjunct Associate Professor of Pharmaceutical Sciences, College of Pharmacy; University of Cincinnati, and the Director of the Capstone project.