Sterilization Procedures, Methods and the Use of Parametric Methods as a Method for Rapid Release of Sterilized Products

Live, Interactive Training Webinar

Date: Tuesday March 19, 2019 Time: 1:30pm - 3:30pm Easterm New York Time
Instructor: Barry A. Friedman Ph.D. Biography>>>

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Training on sterilization procedures and methods is imperative for success in today’s highly regulated and competitive Pharmaceutical, Biotechnology, Medical Devices industries. A variety of sterilization methods within the Medical Device and Pharmaceutical Industries exist for use in today's environment. In addition, with the increasing number of combination products, it is not unusual to find that several sterilization methods might be used sequentially to obtain an acceptable product available to the patient. Historically, steam, dry heat, and chemical sterilants were the prominent modes of sterilization. While steam and dry heat were successful, chemical sterilants have proven to be less reliable. More recent innovations include ethylene oxide, gamma irradiation, filtration and electron beam. Each of these has found a place in today's terminal sterilization market.

Parametric release of sterile products offers many incentives that historically were not offered with steam sterilization followed by sterility testing. Parametric release represents a mode for the “instantaneous” release of a product without the time requirements normally associated with the fourteen day sterility test followed by whatever time requirements were additionally added by Quality Assurance. Thus, the product would not be released for seventeen to twenty days.

The objective of this live and interactive training webinar is to explore the various sterilization methods and learn how they may be used within your current manufacturing operation to provide both sterile components and final product. This live webinar will also explore the use of parametric techniques to permit product release without the requirement for the fourteen day sterility test.

Learning Benefits:
-Types of sterilization methods.
-Predominant uses of sterilization within the Medical Device and Pharmaceutical/Biotech industries.
-Product interactions with Various Modes of Sterilization.
-When to Use one Sterilization Mode vs. Another.
-Parametric Release – What is it?
-How to Use Parametric Methods.
-Development of the Techniques – Issues and Answers.
-Considerations of cost of sterilization.
-Use of contract sterilization vs. in-house.

Webinar outline and time breakdown:

Time*
1:15 PM Log In Period
1:30 PM Introduction
1:40 PM Definitions,
Types of Sterilization Methods,
Predominant Uses of Sterilization,
Product Interactions with Sterilization,
Parametric Release – What is It,
2:30 PM Break
2:40 PM Sterilization Cycle Development and Other Considerations,
How to Use Parametric Methods,
Development of the Techniques – Issues and Answers,
Considerations of cost of sterilization,
Use of contract sterilization vs. in-house,
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 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
  • Validation
  • Auditing Professionals
  • Microbiology Professionals
  • Auditors

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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>>>

 

Course Number: 239

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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

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"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