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Volume discounts are available – 3 webinars for $1000; 5 webinars for $1615; 9 webinars for $3000
We hope you enjoy our recordings, and come back often; this page will be changed regularly as new topics become available.
Trending of environmental monitoring (EM) data is a difficult task, make more so by the arbitrary nature of more regulatory guidance in this area. Alert Levels and Action Levels are frequently set based on “recommendations” that have no basis in your facility’s performance or your process’ requirements. This situation is not acceptable for such a critical monitoring parameter.
This webinar will look at the difficulties inherent in EM data analysis, and provide several suggestions for a more appropriate method of data trending by looking at the frequency of “No Recovery” vs “Recovery” results, rather than looking at the actual number of CFU recovered . While the webinar will focus on recommendations in the new USP Chapter 1116, other means of trending "recovery frequencies" will be discussed.
CMGP lessons can be learned from many sources including 21 CFR (parts 111, 211, 612, etc) as well as guidance documents, USP informational chapters and industry technical reports. Another source of extremely useful information are Recall enforcement reports provided by FDA on their web site. This webinar looks back at a history of recall summaries over the years to determine causes of recalls from a variety of industries regulated by FDA.
While most companies use a version of the harmonized microbial limits tests (USP <61>, <62>) to determine finished product quality for non-sterile manufactured products, the cGMP requirements as described in 21 CFR 211 are for absence of “objectionable” organisms. This webinar discusses the rationale behind this requirement, and provide some guidance on how to determine if an organism is, in fact, “objectionable.”
The microbiologist went to school for years to learn how to work in the laboratory, but upon acceptance into industry is now also expected to have many additional skills. One of the more challenging is the expectation that the lab will be able to qualify (or at least write and review the protocol) its laboratory equipment. Fortunately there is guidance on how to decide which equipment requires qualification of function and how to design the protocol. This webinar focuses on the instruments of the QC microbiology lab using the USP chapter <1058> as a guide for analytical instrument qualification.
The compendial Sterility Test has acquired near-religious stature in the industry since its inception in the early 1930′s. This webinar examines the now internationally-harmonized test in terms of its scope as a regulatory requirement and a scientific test method. The GMP aspects of the test will be discussed in terms of adequate documentation and control for audit review and investigation, as well as it’s role in the product development process and ongoing QC of finished product during manufacture and release to market.
Microbiological assays require recovery and growth of microorganisms. While the Sterility Tests and the Microbial Limit Tests have the “validation” or “method suitability” studies are part of the procedure, many tests do not. USP Chapter <1227> was designed to provide information on the design of these studies, and to provide information on the limitations of the plate count method. This webinar reviews USP <1227> with emphasis on how it can be used to strengthen all assays in the QC microbiology laboratory.
FDAs “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. This webinar relies on USP <1117> “Best Microbiological Laboratory Practices” with input from FDA and PIC/S guidance documents to provide a usable approach for the technical audit of the QC microbiology lab to meet the intent of “CGMP”.
This is a shortened version of a highly successful in-house “Lab GMP” course taught the last 4 years.
The Antimicrobial Effectiveness Test is a well-established test in both the USP and the Pharm. Eur. The goal and scope of this test, however, is not well defined in the literature or the industry’s perception of its value. This webinar examines the strengths (and limitations) of the AET and its place in the microbiology lab testing scheme, as well as how it fits into a product stability program. As microbiology supports product regulatory submissions, the AET will be discussed not only from the QC lab perspective but also its place in product development and the regulatory submission. The GMP aspects of the AET will be discussed with an eye to audits of test results and investigations of questionable results.
The FDA Guidance document on OOS specifically excludes microbiology from its scope, but this does not release the manufacturer from his obligation to investigation product failures for microbiology-based quality specifications. This webinar presents a proven method for performing laboratory investigations to establish the validity of microbiology test results, a method that relies heavily on a well-designed SOP system and proactive documentation. Additional benefits to this method include enhanced GMP compliance and stronger SOP and training programs. The approach presented will also be invaluable in audit and investigation of contract laboratory reports, an area of increased regulatory scrutiny.
There are a variety of different microbial identification technologies available for the QC Microbiology laboratory. Use of these in a CGMP environment requires qualification, but there is little guidance on this activity. This webinar reviews the available technologies, and the proposed guidance in USP <1113> “Microbial Characterization, Identification and Strain Typing” and provide concrete recommendations for design of the qualification process.
