2022 PDA Microbial Data Deviation Investigations Conference
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Program Highlights
The 2022 PDA Microbial Data Deviation Investigations Conference starts this Wednesday, 16 November!
Attend the 2022 PDA Microbial Data Deviation Investigations Conference to get both a recap of the newly developed PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry, as well as real world examples that can be used to develop and improve your current approaches and strategies to manage these events.
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Standard Pricing
Standard Member Price
$1,395Early Career ProfessionalMember Only
$695
Non-Member
$1,695
Day 1
WEDNESDAY, 16 NOVEMBER
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09:00 – 10:25 | P1: Investigation Playbook In this opening session, the presenters will discuss tools and points to consider for conducting effective, thorough, and efficient investigation and root cause analysis. They will focus on how to use your investigation team to determine the true root cause and areas that are often overlooked during a microbial data deviation event. |
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09:00 | Welcome Remarks from Co-Chairs 09:10 | Why Can't I Find the Definitive Root Cause? Important Points to Consider 09:40 | Walking the Talk: The Importance of Microbiology on the Manufacturing Floor |
10:25 – 10:35 | Break
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10:35 – 12:20 | P2: Laboratory Investigations In this session, the presenters will discuss Laboratory, or Phase 1, Investigations in response to microbial data deviations (MDD). Comprehensive and timely lab investigations are critical to establish whether an error was made, which would invalidate the test results so the test may be repeated. The timely completion of the first phase of the investigation is important so a cross-functional team can be put together rapidly to 1) conduct the manufacturing investigation to establish the probable cause of the failure; 2) complete Corrective Actions and Preventive Actions (CAPA) as required by cGMP regulations; and 3) finalize the disposition of the manufacturing batch. The presenters will also discuss the new FDA regulations on quality metrics reporting as they emphasize investigations and are seen as a tool to measure and improve laboratory performance. |
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10:35 | Non-Sterile Product Testing 11:05 | Sterility Test MDD: Concepts for Conducting Laboratory and Manufacturing Investigations 11:35 | Ancillary Testing Micro Data Deviation and Utilities |
12:20 – 12:30 | Break
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12:30 | P3: Day 1 Closing Panel Discussion |
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12:30 | Panel Discussion (25 min) |
Day 2
THURSDAY, 17 NOVEMBER
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09:00 – 10:35 | P4: Manufacturing Investigations In this plenary session, the presenters will expand PDA TR88’s systematic manufacturing investigations approach and provide attendees with a roadmap to improve their contamination control strategy using a structured tool to deal with complex investigations following loss of environmental control in the cleanroom. Beginning with “A Roadmap to a Successful Cleaning and Disinfection Program,” the key concerns in the industry related to their cleaning and disinfection program such as biocidal selection, cleaning frequency, wet contact time, fungal spore outbreaks, rotation, residues, and disinfectant validation will be discussed. Then, “The Restart Process as a Tool in Microbiological Manufacturing Investigations” will propose a structured approach to manage unplanned events which have led to a loss of environmental control, to set the process for driving the environment back to the controlled state, ensuring that the right subject matter experts are involved on the team and the needed tasks (e.g., cleaning and disinfection, EM) are performed sequentially and are satisfactory prior to resuming manufacturing. |
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09:00 | Welcome Back and Recap from Co-Chairs 09:15 | The Restart Process as a Tool in Microbiological Manufacturing Investigations 09:45 | A Roadmap to a Successful Cleaning and Disinfection Program |
10:35 – 10:45 | Break
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10:45 – 12:05 | P5: Sterility Assurance Principles This session will review several elements required to provide sterility assurance in a pharmaceutical manufacturing process. From facility design, utility and environmental monitoring programs to proper gowning and aseptic practices, each of these elements contribute to the quality of a drug product. The presenters will discuss the role that a microbiologist plays in ensuring contamination is controlled in the manufacturing areas, as well as providing quality control in the laboratory when establishing both in-process and finished product release testing. But that's not all, aseptic process simulations and properly investigating contaminating events are all part of the knowledge base that a pharmaceutical microbiologist must possess. Participants will learn how to incorporate these skills into your everyday processes. |
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10:45 | Microbiology Matters: From Bench to Batch 11:15 | Microbiology Contamination Control Considerations |
12:05– 12:25 | Break
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12:25 | P6: Day 2 Closing Panel Discussion |
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12:25 | Panel Discussion |
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