Microbial Data Deviation Investigations, The Role of Deviations, Out of Specifications, CAPAs and Risk Management within Microbial Data Deviations and How the FDA and ICH Regulations and Guidances Impact Them
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to attempting to determine the "root cause" of a sterility test failure. The resultant investigations and their data requirements may be very short in duration, e.g., a matter of only several to 40 – 50 hours. However, unlike chemical analytical deviations and their Out Of Specification (OOS) studies and Corrective/Preventive Action (CAPA) programs, the length of time to complete these microbiological investigation studies may extend to as many as six months based on the laboratory studies that may be required.
The objective of this live training webinar is to explore the more common microbiological aspects of data deviation investigations, and how FDA and ICH regulations and guidances impact them.
-What are the more common microbiological data deviations. -How do these deviations occur? -What solutions exist for minimizing and eliminating these deviations. -How a deviation becomes an OOS and when a CAPA may be required. -How the process may be shortened. -How the use of metrics may provide a “roadmap” for action. -Why trending of deviations, OOS and CAPAs is important for both the site and during regulatory audits. -The role of Risk Management and the relationship to microbial data deviation investigations
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|The Role of Deviations, Out of Specifications, CAPAs and Risk Management within the arena of Microbial Data Deviations,|
|FDA Considerations: -- When Deviations are required? -- When Out of Specifications (OOS) are required? -- When Corrective Actions/Preventive Actions (CAPAs) are required? -- When Risk Management is required?,|
|Elements of Deviations, OOS, CAPAs and Risk Management,|
|11:40 AM||Why trend these data,|
|A Review of the More Common Microbiological Deviations,|
|The impact of Risk Management and relationship to microbial data deviation investigations,|
|12:30 PM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Auditing Professionals
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Instructor: Barry A. Friedman Ph.D.
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>