Wednesday May 1, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
The Laboratory Environment, and, in particular, the Microbiology laboratory, have definite Annual GMP Training requirements that necessitate “refreshing” (see 21 CFR 210/211, Section 25). With a constant influx of new and revised FDA Guidances for Industry, USP General and General Information Chapters, ISO, Canadian and EU requirements, Standard Operating Procedures (SOPs) are always in flux. In addition, with a continuum of Form FDA 483 Observations and Warning Letters providing “new twists” to what is expected of the Microbiology Laboratory Environment, the studying of these FDA compliance documents from a microbiological perspective can be most helpful.
As part of this webinar “refresher”, discussions will include a review of pertinent FDA regulations, FDA Guidance documents and both USP General and General Information chapters. The webinar will also review the “Best Laboratory Practices” as defined by USP<1117>. Issues that may occur based on the presence of mesophilic, aerobic microorganisms which may be found in the air, on surfaces, in water and throughout various raw materials, intermediates, API and finished product will be examined using USP<61> and <62>.
While dilution issues may occur within the Chemistry section of the Quality Control laboratory, their occurrence within the Microbiology laboratory can be devastating and create non-compliance issues throughout the manufacturing operation resulting in the ultimate rejection of the finished product. The webinar will conclude with a review of the issues surrounding “Troubleshooting” for the presence of microorganisms throughout the process and within the final product and how one may determine where they originated and their root cause.
Please plan to attend with a cross-functional group to gain the most from this interactive Executive Conference Corporation webinar.
Training Program Learning Benefits:
– Gain an overall review of cGMP and those sections of 21 CFR 211 that impact the microbiology laboratory.
– Review USP, 21 CFR 211, EP, Canadian, ISO and various FDA Guidances that impact microbiological issues throughout the cGMP environment for the microbiologist within the laboratory/QC operations.
– Learn how microbiology impacts In-coming Raw Materials.
– Review non-sterile production and products and how USP<61>, <62>, and <1115> impact these products.
– Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment.
– Review various Case Studies that involve Form FDA 483s and Warning Letters.
The following should plan to attend:
- Quality Assurance
- Quality Control
- Research & Development
- Regulatory Affairs
- Microbiology
- Manufacturing
- Project Managers
- Those that use contract manufacturing and contract testing facilities
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-596