Regulatory Aspects of Microbiology in a Non-Sterile Environment; Understanding the FDA Regulatory Requirements & USP Non-Sterile Documents Pertaining to Non-Sterile Manufacturing
Live, Interactive Training Webinar
Date: Thursday January 16, 2020
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Barry A. Friedman Ph.D. Biography>>>
Date: Thursday January 16, 2020
Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to aseptic manufacturing. These include the handling and evaluation of non-sterile components, the environment and final product. This two hour live webinar discusses various regulations and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Products that are sold as sterile, but include a non-sterile phase within their manufacturing cycle will also be reviewed since the Regulators often have concerns regarding these in-process materials. Thoughts about in-house microorganisms that may be considered as "specified" will also be discussed. Warning Letters, Recalls and USP Chapters will be used to highlight the various discussion points.
-Review the various Regulations pertaining to non-sterile raw materials, in-process materials and final product. -Examine the various USP documents that discuss the elements associated with the concept of non-sterile manufacturing. -Gather information regarding the impact of process hold times, preservation issues, cleaning, sanitization, and the requirements for the testing of recovered microorganism. -Learn when recovered microorganisms require testing. -Understand why Warning Letters and Recalls were issued for non-sterility .
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|Review of the Regulations,|
|A Review of the Non-sterile Documents Associated with USP,|
|The Impact of Various Hold Times upon the Overall Process,|
|11:40 AM||Requirements for the Testing of Collected Microorganisms,|
|Which In-coming Materials, In-process Materials and Final Products Require Testing,|
|Learn about Sterile Products that Possess a Non-sterile Manufacturing Phase,|
|Learn about Warning Letters and Recall Regulatory Rationale,|
|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
- Microbiology 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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