Bioburden Control Program

A Comprehensive Course on the Key Elements of a Bioburden Control Program, Monitoring of Bioburden and Inherent Methods in Sterile and Non-Sterile Products

Live, Interactive Training Webinar

Date: Monday November 4, 2019 - Time: 10:30 AM - 12:30 PM ET
Barry A. Friedman Ph.D. Biography>>>

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Monitoring of in-process bioburden of pharmaceutical components, containers and closures, intermediates, drug substances and drug products are essential elements of the overall contamination control program for appropriate process control of both non-sterile and sterile products.
A typical bioburden control program includes review and analysis of potential sources of contamination commencing with each of the raw materials to include the Certificate of Acceptance of each. The microbiological contamination control program should be developed to identify and control bioburden and to assess product risk based on ICH Q9 Quality Risk Management. The bioburden risk assessment should result in the establishment of a range of critical control points which will ultimately lead to specifications for each raw material and to each unit operation as well as the drug substance and product.

Several of the major considerations should include:

Microbiological attributes of in-coming raw materials and manufacturing unit operations within the process itself
Antimicrobial effectiveness of the raw materials
Duration of the process
Water activity of the material
Environmental conditions within the facility
Equipment design and cleaning to maintain a low bioburden
Sanitization, disinfection and sterilization, as appropriate

Bioburden should be recovered and enumerated from samples that are representative of each container of in-coming raw materials. When multiple containers of in-coming raw materials are received, they should be analyzed based on a plan developed in concert with Quality Assurance and Quality Control. When the material is stored in separate containers, analysts should consider testing multiple or composite samples.
Bioburden evaluation should focus on microorganisms that represent specified and objectionable microorganisms. Total count methods should consider bacteria, yeast and mold.
Controlling the bioburden of the in-coming raw materials, drug substance and drug product will ensure conformance to the levels required for the various in-process and final product. Additionally, controlling the bioburden levels of the items if the API is to be sterilized assures that residuals (e.g., allergens, endotoxins, and exotoxins) from that population will also be controlled.
The objective of this live, interactive training webinar is to obtain an enhanced understanding of the monitoring of bioburden, its inherent methods, and limitations to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret the final result. It will also consider methods of sterilization and consideration of component bioburden and endotoxin. Please consider having a cross-functional group attend this important training course.

Learning Benefits:
-Examination of a Bioburden Control Program
-Major Elements of a Bioburden Control Program
-What a Vendor Can Tell You through a COA
-What Your Bioburden Evaluation is Telling You
-What Your Bioburden is Telling You about Each Unit Operation
-How Your Bioburden Impacts both Non-Sterile and Sterile Final Products
-Interpretation of the results – regardless of a pass or failure
-Review of pertinent Warning Letters.

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Examination of a Bioburden Control Program,
Exploring the Elements of a Bioburden Control Program,
What Your Bioburden Evaluation is Telling You,
11:30 AM Break
11:40 AM Focusing In upon Specified and Objectionable Microorganisms,
How the Bioburden May Impact Your Final Sterilization Mode, if Sterility is Required ,
Interpreting the Results of a Sterility Pass or Failure,
Review of Pertinent Case Studies/Warning Letters,
12:30 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:

  • In-coming Component/Raw Materials
  • Quality Assurance
  • Quality Control
  • Manufacturing
  • R&D


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: 233

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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