Upcoming Webinars

The Microbiology Network was established in 1996 and provides consulting, training and expert witness services to industry.  Our on-line training focus is QC microbiology in the regulated industries.  These webinars range from applied topics geared to solving problems and questions at the bench, to academic presentations of current research for your continued development.  We try to being meaning to the phrase “science-based regulation”.

Upcoming Webinars:

Review of Microbiological Involvement in Product Recalls

Webinar to be presented Thursday, February 9

Abstract

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 at causes of recalls from a variety of industries regulated by FDA.

A recent analysis was conducted of 642 microbiologically-related recalls over the years 2004-2011. The microbiologically-related recall activity shows a decided increase in recent years. Most of the reported recalls involved sterile products, and of these medical devices accounted for the majority. The reasons given for sterile product recalls were varied, but the majority cited “Lack of Sterility Assurance” with sterile packaging clearly identified as the main culprit.

There was significant information in the recall data for non-sterile products as well. The majority of the recalls came from OTC and personal care products, with “Objectionable Organisms” as the most prevalent reason for recall by a wide margin. These recalls are further analysed to provide indication of the FDA policy on what is an objectionable organism, along with a review of current regulatory guidance. Finally, recommendations are presented in determining an “Absence of Objectionable Organism” policy for a manufacturer.

What are “Objectionable Organisms?”

Webinar to be presented Thursday, February 23 at 2 pm EST

Abstract

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 will discuss the rationale behind this requirement, and provide some guidance on how to determine if an organism is, in fact, “objectionable.”

Validation of Microbial Recovery – Method Suitability Studies

Webinar to be presented Thursday, March 8 at 2 pm EST

Abstract

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 will review USP <1227> with emphasis on how it can be used to strengthen all assays in the QC microbiology laboratory.

Topics in the Antimicrobial Effectiveness Test

Webinar to be presented Thursday, March 22 at 2pm EST

Abstract

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 will examine 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.

Investigations of Microbiological Data Deviations

Webinar to be presented Thursday, April 5 at 2pm EST

Abstract

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 will present 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.

Technical Qualification of the Contract Microbiology Lab

The webinar is scheduled for Thursday, April 19 at 2 pm EST

Abstract

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 will rely 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 5 years.

Improving the Environmental Monitoring Program

Webinar to be presented Thursday, May 3 at 2 pm EST

Abstract

Environmental monitoring in pharmaceutical production areas is performed to demonstrate the state of control of the facility. Methods used for environmental monitoring should therefore be accurate and precise, allowing clear and unambiguous interpretation. Unfortunately, the methods available to us are anything but clear and unambiguous.
There are several types of sampling used in a modern EM program, primarily sampling of surfaces, air, utilities and personnel. While some of these incorporate a physical component, all have a microbial component and this will be the focus of the presentation. We will look at the ability of these methods to provide a realistic evaluation of the state of control of the facility, and opportunities for alternate microbiological methods to help in this program.

Topics in the Sterility Test

Webinar to be presented Thursday, May 17 at 2 pm EST

Abstract

The compendial Sterility Test has acquired near-religious stature in the industry since its inception in the early 1930′s. This webinar will examine 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 its role in the product development process and ongoing QC of finished product during manufacture and release to market.

The Most Probable Number (MPN) Method – Let’s Expand our Toolbox in the QC Microbiology Lab

Webinar to be presented Thursday, May 31 at 2 pm EST

Abstract

The “Most Probable Number” (MPN) Method is a useful, if underutilized, tool for the microbiologist. It is part of the harmonized compendial chapter on bacterial enumeration and has been part of the Microbial Limits Test chapter in USP since the chapters inception in USP XVIII (1970). The test is a method to estimate the concentration of viable microorganisms in a sample by means of replicate liquid broth growth in ten-fold dilutions. It is particularly useful with samples that contain particulate material that interferes with plate count enumeration methods.
The method offers real opportunities as a tool for microbiologists in situations where, for one reason or another, the plate count method is unsuitable. It can also be employed for semi-quantitative estimation of growth-promotion capability of liquid media, in estimation of precision for alternate microbiological methods, and as part of the “fraction negative” method of determining D-values.

Qualification of Microbial Identification Technology – USP <1113>

Webinar to be presented Thursday, June 14 at 2 pm EST

Abstract

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 will review 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.

What are “Objectionable Organisms?”

Webinar to be presented Thursday, June 28 at 2 pm EST

Abstract

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 will discuss the rationale behind this requirement, and provide some guidance on how to determine if an organism is, in fact, “objectionable.”

Validation of Microbial Recovery – Method Suitability Studies

Webinar to be presented Thursday, September 13 at 2 pm EST

Abstract

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 will review USP <1227> with emphasis on how it can be used to strengthen all assays in the QC microbiology laboratory.

Qualification of Equipment in the Microbiology Lab

Webinar to be presented Thursday, September 27 at 2 pm EST

Abstract

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 will focus on the instruments of the QC microbiology lab using the USP chapter <1058> as a guide for analytical instrument qualification.