Developing an Autoclave Validation Plan in a cGMP Environment
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
Terminal moist heat sterilization is presently considered the method of choice to ensure sterility. An autoclave validation plan and its implementation are considered critical elements of any Site Validation Plan in a cGMP environment to assure this sterility. Often, facilities that require an autoclave for terminal sterilization find that the need to sterilize "goods" under cGMP is required earlier than any other subsequent sterilization method to achieve this Plan.
Elements that often require autoclaving include raw materials, glassware, tubing, stoppers, media, buffers, etc. In addition, since biotechnology products are required to be "safe", even in Phase 1, components, in-process and final products must be sterile for the product to be "fit for use" for the patient.
This webinar will review three strategies for the validation of moist heat sterilization. Emphasis will be placed upon "Prospective Validation" which applies to new or modified process and equipment systems certified prior to initiating routine production. "Concurrent Validation", which applies to existing processes and equipment, will also be reviewed as will "Retrospective Validation" which is based on historic information. The latter will be discussed in relationship to the new FDA Guidance for Industry on "Process Validation".
The objective of this live and interactive webinar training is to explore the requirements for the three above strategies of sterilization validation, frequency of validation, and review when an autoclave may be qualified vs. revalidated. It is applicable to anyone conducting a validation within North America, the European community or Japan.
-The IQ/OQ/PQ Requirements for Autoclave Validation. -Consideration of Cycle Time in the Overall Autoclave Utilization Plan. -Determination of "Cold Spots" using Thermistors. -Issues that Arise when Using Thermistors and Biological Indicators. -Why Biological Indicator Failures may not be Failures. -Number of Required Replicate Cycles as a Component of Validation. -When to use One Sterilization Validation Mode vs. Another. -Verification/Qualification vs. Revalidation. -Considerations of Cost of Sterilization. -Use of Contract Sterilization vs. In-house Usage.
Webinar outline and time breakdown:
|12:45 PM||Log In Period|
|Performance Qualification (PQ) Requirements,|
|Validation Protocol Development,|
|Equipment Qualification - Installation, Operation, Performance,|
|02:10 PM||Sterilization Cycle Development and Other Considerations,|
|03:00 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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