Developing an Autoclave Validation Plan in a cGMP Environment

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

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.

Learning Benefits:
-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
01:00 PM Introduction
01:10 PM Definitions,
Performance Qualification (PQ) Requirements,
Validation Protocol Development,
Equipment Qualification - Installation, Operation, Performance,
02:00 PM Break
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
  • Manufacturing
  • Auditing Professionals
  • Microbiology Professionals

Schedule & Deliver this Live Training Webinar Privately to Your Group

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>>>


Course Number: 244

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

Live Training Benefits:

• Pharma Webinars training webinars and programs are presented exclusively as live events only.

• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.

• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.

• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.

• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.

• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.

• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.

• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.

• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.

Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland