Use and Application of Sanitizers, Disinfectants and Sterilants in a GMP Controlled and Classified Environment, Key Elements of a Robust Cleaning and Disinfection Program & Latest USP and FDA Requirements

A Comprehensive 2-Part Live Webinar Training Program

Part 1: Thursday January 24, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Part 2: Thursday January 31, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)

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

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Click Here to Register for this 2-Part Interactive, Live Training Program ►


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.

Maintaining this controlled environment also requires knowledge of the microorganisms present and their susceptibility to various sanitizers, disinfectants and sterilants. Whether the final product is non-sterile or sterile, the bioburden exists throughout the process and/or within the product's environment. A critical review of the overall microbiological process will determine whether the critical “in-process” points permit the final product to meet its acceptance criteria (specifications).

The determination of which disinfectant to use is largely dependent upon the site of application and the type of microorganism present. For example, Gram positive cocci are very easy to kill, while spore forming rods and fungi are more resistant. Other elements that need to be considered include the biocidal activity and its contact time, surface of application, concentration of microorganisms, and secondary issues to include water hardness and organic materials. In addition, surface films may also interfere with the direct contact of the microorganism and the disinfecting agent. Any "objectionable" or "specified" microorganisms that may be encountered during the procurement of raw materials and the processing must also be considered.

Whether you are auditing a raw material supplier, a testing laboratory, or your own facilities, you should be aware of the critical role the microorganisms play throughout. You should be aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, to determine whether the SOPs, internal validations as well as government and other regulatory body documents are being maintained to control the bioburden and permit the final product to enter the marketplace as microbiologically safe.

The objective of this live, interactive two part training webinar is to explore the use of various sanitizers, disinfectants and sterilants within a controlled environment, learn which materials may be appropriate for your facilities’ operations and to assure that you are complying with your own SOPs, governmental and regulatory guidances and regulations.

Please scroll down for complete details of both parts of this exclusive live training program.


Part 1 - Use and Application of Sanitizers, Disinfectants and Sterilants in a GMP Controlled and Classified Environment – Latest Regulatory Requirements & Guidance

Live, Interactive Training Webinar

Date: Thursday January 24, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)

Learning Benefits:
-Learn the latest Regulatory Expectations of Sanitizers, Disinfectants and Sporicides
-Determining of the Vendor Qualification Requirements
-How to Develop an Application Schedule
-Determination of how Application Schedules Apply to Commissioning of a Facility and After a Shutdown
-Learn of the Impact of Sanitizers, Disinfectants and Sporicides on Various Common Microorganisms Found within a Pharmaceutical Facility
-Impact of Product Expiration Dating and Regulatory Implications

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions; Regulatory Expectations of Sanitizers, Disinfectants and Sporicides,
Determining the Vendor Qualification Requirements,
Development of an Application Schedule,
Determination of how Application Schedules Apply to Commissioning of a Facility and After a Shutdown,
11:30 AM Break
11:40 AM Impact of Sanitizers, Disinfectants and Sporicides on Various Common Microorganisms,
Impact of Expiration Dating from a Regulatory and “Real World” Perspective,
Review of Selected Warning Letters,
12:30 PM Live Questions & Discussion

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


Part 2 - 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

Date: Thursday January 31, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)

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*
10:15 AM Log In Period
10:30 AM Introduction
10:40 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,
11:30 AM Break
11:40 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,
12:30 PM 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

Click Here to Register for this Interactive, Live Training Program >


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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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