A Comprehensive Training on the Application of Steam in Place (SIP) Within a Manufacturing Facility & Methods to Destroy Microorganisms

Live, Interactive Training Webinar

Date: Thursday January 31, 2019
Time: 1:30pm - 3:30pm ET (New York Time)
Instructor: Barry A. Friedman Ph.D. Biography>>>

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Steam in Place represents an important technique that facilitates the management of microorganisms in environments ranging from foods to dietary supplements to pharmaceutical products. When this technique is applied properly, it provides a microbiological assurance that may range from sanitization to sterilization. The primary application of Steam in Place is to provide a significant temperature for a specified time to either reduce or provide a Sterility Assurance Level (SAL) for the death of microorganisms. This methodology finds application primarily with equipment.

Steam in Place, PDA Technical Report No. 61, provides a detailed overview of issues related to the rendering of a surface or product devoid of microorganisms. This process may sterilize the product or only reduce the bioburden. As with other forms of sterilization, concepts of Sterility Assurance levels (SAL) with dry heat, ethylene oxide and cobalt irradiation apply to Steam in Place (SIP). This live training webinar will review the application of SIP and discuss its mechanism of lethality. The system design for a SIP cycle will be covered to include its control and monitoring. Cycle development considerations will delve into the area of Risk Management (ICH Q9) and how it impacts cycle parameter development. Once all of these elements are in place, performance qualification will be reviewed and include both the physical and biological qualifications and challenges. Examples will be provided throughout the live training webinar.

The objective of this live training webinar is to explore the development of Steam in Place and how it may be utilized to provide either the sanitization or sterilization of equipment without its incorporation into an autoclave or subjecting the equipment to another mode of sterilization. Because of the sensitivity and importance of Steam in Place to a variety of facility applications, this live training webinar is a MUST for anyone in your organization that is involved in the removal of microorganisms through sanitization or sterilization.

Learning Benefits:
-Review Steam in Place Applications within a Manufacturing Facility .
-Learn of the Mechanisms of Lethality.
-Understand how a System Design may Impact the Control and Monitoring of a SIP System.
-Review System Design Considerations within a SIP System.
-Learn about Risk Management Re: Cycle Development.
-Review Physical and Biological Performance Qualifications.
-Case studies within SIP.

Webinar outline and time breakdown:

Time*
1:15 PM Log In Period
1:30 PM Introduction
1:40 PM Definitions,
Overview of Steam in Place applications within manufacturing,
Mechanisms of Lethality with steam,
System Design considerations with a SIP System,
2:30 PM Break
2:40 PM System Design and its impact on the control and monitoring of a SIP system ,
Risk Managements during cycle development,
Review of Physical and biological performance qualifications,
Case studies within SIP,
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
  • Validation
  • Incoming Materials and Receiving.

Member Registration ►

Registration Form ►



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: 230

This live training webinar is a MUST for anyone in your organization that is involved in the removal of microorganisms through sanitization or sterilization.

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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

"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