Microbiological Issues In Non-Sterile Manufacturing & FDA Regulatory Expectations
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
Non-sterile manufacturing involves issues and challenges many times overlooked in aseptic operations. These include the handling and evaluating of non-sterile components, environments and products. This live training webinar discusses various issues in non-sterile manufacturing including 1) establishing analytical procedures and acceptance specifications, 2) setting of specifications, 3) process development, 4) preservation, 5) holding times, 6) cleaning, 7) sanitization, and 8) approaches to evaluating recovered organisms. It will address how one determines what a “specified” or “objectionable” microorganism is and why the FDA’s “Bad Bug” book will not necessarily provide a solution. It will also discuss methods for enumeration of these microorganisms and why microbiological examination of the in-coming materials and the manufacturing process are critical to eliminating potential recall issues. It will also briefly consider USP <1115> Bioburden Control of Non-Sterile Drug Substances and Products– A New Proposed USP General Information Chapter.
This live training webinar is for pharmaceutical, cosmetic, neutraceuticals and other industries that produce product not labeled as sterile. Those in both decision and non-decision making capacities will benefit.
-Identify the regulatory concerns in non-sterile manufacturing.
-Discuss key issues in manufacturing non-sterile products
-Review of an established non-sterile microbiological control program.
-Identify gaps within current regulatory and industry expectations.
-Examine the new FDA “attitude” that is being taken with non-sterile product.
-Explore Form FDA 483s and Warning Letters that have recently been issued.
Webinar outline and time breakdown:Time*
|1:15 PM||Log In Period|
|Establishing Analytical Procedures and Acceptance Specifications,|
|Microbiological Methods Used in Non-Sterile Manufacturing,|
|2:40 PM||Microbiological Attributes of Non-Sterile Pharmaceutical Products,|
|Role of Water Activity, DRAFT USP<1115>, FDA attitudes|
|Form FDA 483s and Warning Letters,|
|3:30 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 participation for attendee training 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
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>>>
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