2023 PDA Microbial Data Deviation Investigations Workshop
Registration Options
Individual Registration
Group Registration
Program Highlights
Takeaways include:
- Understanding how to search for root cause and resolving sterile product microbial mishaps
- Getting insights and points to consider on conducting laboratory investigations
- Hearing about the current FDA guidance on properly executing microbial data deviations
- Learning how to de-risk microbial excursion potential based on smart facility and utility design, and what to do for legacy facility designs
- Gaining tools for determining potential sources of contamination when assessing objectionable organisms found in non-sterile drug products
A key feature of this interactive workshop is that every plenary session will include a case study!
Microbiological data deviations result from microbial test results that fall outside the product specification or acceptance criterion established in a drug application, drug master file, official compendia, good manufacturing practice regulations, or internally by the manufacturer. The term "microbial data deviation" is preferred to "out-of-specification" or "out-of-limit result," as most microbiological tests, especially in a sterile product manufacturing facility, are in-process tests, not finished- product tests that must meet a regulatory-approved specification. This is an area of continued focus for regulatory authorities during inspections and document reviews. However, it is also an area of limited guidance from health authorities.
Attend the 2023 PDA Microbial Data Deviation Investigations Workshop to provide additional information following the 2022 MDDI Conference as well as get both a recap of the newly developed PDA Technical Report No. 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (TR88), as well as real world examples that can be used to develop and improve your current approaches and strategies to manage these events.
PROGRAM PLANNING COMMITTEE
- Marc Glogovsky, ValSource, Inc. (Co-Chair)
- Christopher Murdock, Bristol Myers Squibb (Co-Chair)
- Elizabeth Brockson, Takeda
- Vanessa Figueroa, Quality Executive Partners
- Djamila Harouaka, U.S. FDA
- Paula Peacos, ValSource, Inc.
- James Polarine, STERIS Corporation
- Kim Sobien, ValSource, Inc.
Contact
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Standard Pricing
Standard Member Price
$2,095GovernmentMember Only
$895
Health AuthorityMember Only
$895
Early Career ProfessionalMember Only
$1,395
StudentMember Only
$595
AcademicMember Only
$895
Non-Member
$2,495
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Day 1
WEDNESDAY, 04 OCTOBER
12:00 – 18:00 | Registration Open
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13:30 – 15:15 | P1: Navigating Laboratory Investigations: Don't Get Lost in the Maze! |
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13:30 | Welcome Remarks from Workshop Co-Chairs 13:45 | Assessing the Impact and Risks Associated with Recovered Microorganisms in Laboratory Investigations 14:05 | Endotoxin Investigations: A Practical Approach for Laboratory Investigators 14:25 | Case Study: Seek and Ye Shall Find: Laboratory Investigations for Sterility Test Failures |
15:15 – 15:45 | Networking Break in the Exhibit Area
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15:45 – 17:15 | P2: What to do Without a CFU? |
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15:45 | Modern Microbiological Methods and Associated Data Analysis 16:05 | A Modern and Holistic Approach in Pyrogen Testing 16:25 | Case Study on Rapid Recovery: How to Conduct Meaningful Root/Cause Analysis with Rapid Methods |
17:15 – 18:30 | Networking Reception in the Exhibit Area
Day 2
THURSDAY, 05 OCTOBER
07:00 – 16:00 | Registration Open
07:00 – 08:00 | Continental Breakfast
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08:00 – 09:30 | P3: Facilities and Utilities: Smarter Design, Reduced Risk Has your facility ever suffered from unplanned down time? Do you really understand what goes on above the ceiling and behind the walls of your cleanrooms? Attendees of this session will learn how to de-risk microbial excursion potential based on smart facility and utility design, and what to do for legacy facility designs. |
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08:00 | Are There Holes in Your HEPA-Filter Integrity Testing? 08:20 | Leveraging Pre-Fabricated Solutions to Reduce Risk 08:40 | A New Angle? Or a Dead End? A Case Study on Purified Water System Excursions |
09:30 – 10:00 | Networking Break in the Exhibit Area
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10:00 – 11:30 | P4: Navigating the Realm of Non-Sterile Drug Product Investigations |
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10:00 | To Release or Not to Release? Assessment for Objectionable Organisms in Non-Sterile Products 10:20 | Non-Sterile Drug Microbial Deviations: A CDER Microbiologist's Perspective 10:40 | Case Study: A Day in the Life of a Black Mold |
11:30 – 12:30 | Lunch
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12:30 – 14:00 | P5: Most Probable at Best: Investigating Sterile Product Microbial Data Deviations |
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12:30 | Investigating the Inevitable: Going Back to Where it Starts 12:50 | Investigating Environmental Monitoring Excursions from Classified Cleanrooms 13:10 | Case Study: 503B Sterility Investigations with Alternative Microbiological Methods |
14:00 – 14:30 | Networking Break in the Exhibit Area
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14:30 – 16:00 | P6: Panel Discussion and Wrap Up We will wrap up our Workshop with a panel discussion, including one presenter from each of our plenaries. Attendees will have the opportunity to ask any remaining questions regarding the importance of performing thorough microbiological investigations. A thorough investigations offers us the opportunity to identify problems, the root cause and implement meaningful CAPA to mitigate potential repeat events, thus improving our processes and even more importantly ensuring timely supply of necessary medicines to our patients. We hope you can bring back what was learned throughout the Workshop and implement it with your organizations. |
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15:00 | Panel Discussion 15:45 | Closing Remarks from Workshop Co-Chairs |
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The Workshop hotel room block is closed. We recommend calling the Grand Hyatt for reservations or booking online for the best available rate.
Reservations
Phone: +1 (202) 582-1234
Online: Click on the reservation link above
The Grand Hyatt Washington is located in downtown Washington, DC, just blocks away from the National Mall. Immerse yourself in the historic sights, shopping, and alluring nightlife of the nation's capital. Whether you're visiting for business or pleasure, you'll enjoy exceptional comfort and service, as well as a direct connection to the city via the Metro Center station.