Technical Qualification of the Contract Microbiology LabThe webinar is scheduled for Thursday, April 19 at 2 pm ESTAbstractSelection of the right contract laboratory partner can be a great asset to the organization, or it can open the company to recalls and seizures. Recent news has provided examples of poorly performing contract facilities that have resulted in significant penalties for the companies that trusted them with testing of products. It is important to inspect the technical abilities of your contract lab suppliers (especially in microbiology), not only their Quality System. FDA’s “System-Based” approach to audits encourages the audit of the laboratory controls not only from the GMP-documentation perspective (the traditional “Quality” audit) but also from the technical perspective. This is a challenge for many inspectors who may not have years of experience at the microbiology bench to provide a perspective on the task. We will discuss USP <1117> “Best Microbiological Laboratory Practices” with input from FDA and PIC/S guidance documents as practical resources for the technical audit of the QC microbiology lab. Learn how to use these freely available resources to protect your company from poor lab work by the contract lab (or even your internal lab). This is a shortened version of a highly successful in-house “Lab GMP” course taught the last 5 years. Register Here!Scott Sutton, Ph. D.
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