Bring the convenience and focus of webinars into your facility at a time of your choosing. Contact firstname.lastname@example.org for information on how to arrange for these standard, 60 minute webinars to be made available for training of your personnel. All webinars can also be customized for your specific training needs (pharma GMP, FDA GMP, FDA compliance training, etc.).
Available webinars are available in the following main areas:
All webinars are presented by Scott Sutton, Ph.D.
Additional topics can be developed to meet your company’s particular training requirements.
Control of the microbial quality of non-sterile products is a difficult operation. On the one hand, the products are known to be contaminated with microorganisms. On the other, just which microorganisms are permissible and which are “objectionable” can be difficult to determine. This webinar reviews control and monitoring strategies for non-sterile manufacturing facilities, processes and finished products with an eye to controlling exposure to excess bioburden.
Recommendations are provided on facility cleaning & sanitization, process/product control and monitoring, and environmental monitoring in non-sterile production.
Investigations of Microbiological Data Deviations (MDD)
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. The approach presented will also be invaluable in audit and investigation of contract laboratory reports, an area of increased regulatory scrutiny.
GMP for the Microbiology Lab
The QC microbiology laboratory is subject to some specific GMP concerns on the basis of the work performed and the technology available. Most microbiological techniques are heavily operator-dependent, and this has real impact on training issues, investigations and all other aspects of the work performed. This hour-long presentation reviews GMP issues in the microbiology lab and will be useful as an introduction, or a review, of the topic. Those preparing for an audit, or preparing to audit another lab, will find this webinar to be especially useful.
This webinar is an abbreviated version of the extremely popular in-house course on Microbiology Laboratory GMP.
Updates of USP <1117> – Best Laboratory Practices
The compendial chapter on laboratory practices has become de facto cGMP for the QC microbiology lab. This webinar discusses the chapter with emphasis on changes proposed that may affect resource allocation, hiring decisions and sample handling and incubation conditions. Do not miss this overview to gain a perspective on the potential changes to this chapter that may effect your lab.
Qualification of Equipment in the Microbiology Lab
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 its laboratory equipment (or at least write and review the protocol). 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.
Topics in Finished Product Testing
The Antimicrobial Effectiveness Test (AET)
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 microbiology supports product regulatory submissions, the AET will be discussed not only from the QC lab perspective but also its place in product submissions. The GMP aspects of the AET will be discussed with an eye to audits of test results and investigations of questionable results.
The Microbial Limits Tests (MLT)
The microbial limits tests have recently been harmonized internationally. These tests represent the minimum in acceptable microbial quality for non-sterile monographed products, but are frequently used for purposes completely unsuited to their design. This webinar examines the tests from the perspective of what they are capable of telling us about product quality and contract this with the GMP expectations in the USA. In addition, we will look at the role of the tests in process control and product release, in product development and the essential documentation to defend testing during an audit or in conducting an investigation.
What are “Objectionable Organisms”?
While most companies use a version of the harmonized microbial limits tests to determine finished product quality for non-sterile manufactured products, the cGMP requirements 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 Sterility Tests
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.
Laboratory QC Operations
The topics listed below are available for focused treatement of the specific topic in the QC microbiology lab and are appropriate for laboratory personnel, QUALITY Assurance personnel responsible for reviewing the laboratory writeups, and auditors who which more in-depth knowledge of the particular topic.