Validation of Microbial Recovery; A Comprehensive Review of Microbial Recovery Methods & USP Microbial Methods Relationship to Method Suitability
Live, Interactive Training Webinar Available Live On-Demand
Barry A. Friedman Ph.D. Biography>>>
Available Live On-Demand
Microbial Recovery is an often discussed topic within both non-sterile and sterile environments with microorganisms. Microbial Recovery concerns itself with in-coming raw materials whether chemicals or containers, in-process products, Active Pharmaceutical Ingredients (API), or finished product. Microbial Recovery is also an important element of both HVAC and water utility systems. No pharmaceutical element with either small or large molecules is more comprehensive than that involving microorganisms. USP covers the many elements of Microbiological Recovery through its various General and General Information Chapters. Similarly, both the European and Japanese Pharmacopeia do the same. Some of these chapters include: USP<51>, USP<61>, USP<62>, USP<71>, USP<1111>, USP<1116> and USP< 1223>.
A variety of issues with each of these compendial documents make them potentially difficult tests to understand, develop and follow within one’s laboratory. Everything from Growth Promotion testing of the media to assuring no issues with “Suitability of the Method” (bacteriostasis/fungistasis) of the raw material through product to be tested requires the knowledge and assurance that the test is being completed as required. In addition, the number of units necessary for testing, the total volume required for the test and assurance that the media is providing accurate results all become important aspects of assuring the test is performed properly and the final result meet those specifications. Finally, a correct interpretation of the results and use of the proper procedures require a thorough knowledge of the various compendia.
Any failure of any one of these various compendial methods or its components will cause one to potentially review all of the elements within the test methods that were involved in developing the process that would provide the final non-sterile or sterile end product. Tests for these compendial methods are most often performed under aseptic conditions within an ISO Class 5 hood although this degree of asepsis is not always required. Precautions are required to assure that neither microorganisms from the individual testing or the environment contaminate the materials being tested. The working condition of the area in which the test is performed should be monitored regularly by appropriate sampling of that working area and by using appropriate aseptic methods to provide control. Each of these areas will be discussed in detail.
The objective of this live training webinar is to obtain an enhanced understanding of the various USP microbial methods and their relationship to method suitability, their inherent method, limitations, sampling quantities and volumes to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret and utilize the final result, regardless of whether it represents a pass or a failure. Review of Case Studies/Warning Letters will also be reviewed to further explain this document.
-Learn of the various Methods of Microbial Recovery.
-Review the Overlap of the Various Methods.
-Determination of the Microorganisms to Use as Controls.
-Review of the Media to Use and Why.
-How to Select the Appropriate Technique for Testing.
-Use of Diluents with Various Testing Methods.
-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|
|Test Background, Methods of Compendial Testing, Comparison of Various Suitability Study Methods, Media Used,|
|Articles and Number Required for Testing, Growth Promotion and Suitability Method Testing|
|11:40 AM||Time Frame Related to Testing including Other Assays Historically Used,|
|Choosing the Appropriate Method, Training the Personnel,|
|Interpreting the Results of a Compendial 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 participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Microbiology personnel
- Those that use contract manufacturing and contract testing facilities
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Regulatory Compliance
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>>>
All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.
Live Training Benefits:
Live Training Benefits:
• Pharma Webinars training webinars and programs are presented exclusively as live events only.
• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.
• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.
• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.
• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.
• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.
• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.
• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.
• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.