Online Learning
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We hope you enjoy our recordings, and come back often; this page will be changed regularly as new topics become available.
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What Are “Objectionable Organisms?”
Scott Sutton, Ph.D.
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.”
Key Topics
- USP vs 21 CFR 211
- Chapter <1111> and the rationale for “other organisms”
- How to streamline the research/justification
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Qualification of Equipment in the Microbiology Lab
Scott Sutton, Ph.D.
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.
Key Topics
- Components of Data Quality
- Analytical Instrument Qualification Process
- Roles and Responsibilities
- Software Validation
- Change Control
- Documentation
- Instrument Categories
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Topics in the Sterility Test
Scott Sutton, Ph.D.
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 as pects 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.
Key Topics
- Sterility Test
- What it can do
- What it can’t do
- Technical Considerations
- Proactive Documentation
- Demonstration of Method Suitability
- Investigations
- Regulatory Issues
- When performed In Product development?
- Where included In the eCTD
- Technology Transfer & Change Control
- The CBER Proposed Test
- Other Considerations
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Validation of Microbial Recovery – Method Suitability Studies
Scott Sutton, Ph.D.
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.
Key Topics
- Influential Factors
- Methods of Neutralizing Antimicrobial Properties
- Validation of Neutralization Methods – Recovery Comparisons
- Recovery of Injured Organisms
- Specific Tests
- Sterility Test
- Microbial Limits: Enumeration
- Microbial Limits: Absence of Specified Organisms
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Technical Qualification of the Contract Microbiology Lab
Scott Sutton, Ph.D.
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.
Key Topics
- What do the GMPs really say about microbiology and the perils of over-reliance on 483s for guidance
- Laboratory Systems
- Aseptic Technique, basic microbiological practices
- Control of Media
- Control of Microbial Cultures
- Control of Equipment
- Lab Lay-out and Operations
- Sample Handling
- Microbiological Media Incubation Times
- Training of Staff
- Laboratory Resources
- Control of Data and Documentation
- Interpretation of Results
- Selection of Methods
- Management Oversight
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Topics in the Antimicrobial Effectiveness Test
Scott Sutton, Ph.D.
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.
Key Topics
- Antimicrobial Effectiveness Test
- What it can do
- What it can’t do
- Technical Considerations
- Proactive Documentation
- Demonstration of Method Suitability
- Investigations
- Regulatory Issues
- When performed In Product Development?
- Where included in the eCTD
- Technology Transfer & Change Control
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Laboratory Investigations of Microbiological Data Deviations
Scott Sutton, Ph.D.
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.
Key Topics
- The Investigation
- Specific Investigations
- Identification
- Environmental Monitoring
- Test Types
- Corrective Action Plan/Closing the Investigation
- Investigating the Contract Lab
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Qualification of Microbial Identification Technology – USP <1113>
Scott Sutton, Ph.D.
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.
Key Topics
- Available technologies for microbial Identification
- Chapter <1113> “Microbial Characterization, Identification and Strain Typing” (draft)
- How to choose among the technologies
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