Development and Implementation of a Robust Cleaning and Disinfection Program & The Use of USP <1072>, <1227> and <51> within the Development of Disinfectant Efficacy Programs

Live, Interactive Training Webinar

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Barry A. Friedman Ph.D. Biography>>>

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Microbiology plays a role, though often not kind, throughout the manufacture of pharmaceutical products. Both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process which may include the raw materials, in-process operations and final product. The environmental and utility systems must also be maintained as must the packaging components, manufacturing equipment, and personnel. To maintain this controlled process and environment, sanitizers, disinfectants and sterilants (sporicides) are essential.

Learning Benefits:
-Learn how to Develop a Cleaning and Disinfection Program
-Determine the Implementation Aspects of a Cleaning and Disinfection Program
-Monitoring and Interpretation of the Results of the Cleaning and Disinfection Program
-Understand Resistance and Rotation of Disinfectants and Its Meaning to the Facilities
-The Use of USP<1072>, <1227> and <51> within the Development of Disinfectant Efficacy Programs
-A Review of Case Studies and Selected Warning Letters

Webinar outline and time breakdown:

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Definitions,
Development of a Cleaning and Disinfection Program,
Implementation of a Cleaning and Disinfection Program,
Monitoring and Interpretation of the Results of the Cleaning and Disinfection Program,
Resistance and Rotation and Its Meaning to the Facilities,
10:30 AM Break
10:40 AM The Use of USP<1072>, <1227> and <51> within the Development of Disinfectant Efficacy Programs,
A Review of Case Studies and Selected Warning Letters,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

List of handout materials included with this training program:

  • A Copy of the presentation slides
  • Reference to the ICH Guidances

Who should attend:
The following individuals or disciplines will benefit from attending this training program:

  • Facilities
  • Microbiology Professionals
  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • 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: 249

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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