2023 PDA Contamination Control Strategy Workshop (Raleigh)
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Program Highlights
Join us in Raleigh for the 2023 PDA Contamination Control Strategy Workshop – PDA’s most interactive workshop ever!
Key to this workshop is more than eight hours of hands-on small group activities and discussions facilitated by recognized industry experts. Learn not only the theory of developing a great contamination control strategy (CCS), but also how to translate that theory into actual practice. Gain the skills you need to create holistic contamination control strategies covering all aspects of the manufacturing operation, including facility design and utilities, environmental control, validation and monitoring, quality systems, people, and processes. This workshop is based on PDA’s newest Technical Report, PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR 90), which will be provided free to each participant as a tool to prepare for the workshop. Jumpstart your CCS understanding and how to apply it to your manufacturing facilities and processes in this world-class interactive workshop – your hands-on solution to developing and implementing a successful CCS!
SUBJECT MATTER EXPERTS
- Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals and Workshop Co-Chair
- Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi and Workshop Co-Chair
- Frederic B. Ayers, Research Scientist, Eli Lilly and Company
- Bianca Bohrer, Managing Director, PSM GmbH
- Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
- Jason Gale, Microbial Control Manager, Pfizer Inc.
- Liliana Gamboa, MSc, Head of Biologics Microbiological Control, Sanofi
- Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.
- Thorsten Haefner, MBA, Vice President of Business Development, PSM GmbH
- Madison Hoal, Global Technical Consultant, Ecolab Life Sciences
- Chris Knutsen, PhD, Technical Fellow, Microbiology, Bristol Myers Squibb
- Patrick Mains, Senior Consultant, ValSource, Inc.
- Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.
- Donald C. Singer, MA, ASQ Fellow, CPGP, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences
- Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK
- James Wamsley, Consultant, ValSource, Inc.
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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, 01 MARCH
08:00 – 17:30 | Registration Open
08:00 – 09:15 | Continental Breakfast
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09:15 – 11:00 | P1: A Path for Quality and Safety In this opening session, the presenters will review PDA’s approach to the development of a contamination control strategy. Using a case study, they’ll also discuss how to identify contamination risks, embed quality risk management (QRM) risk principles, and implement appropriate controls. |
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09:15 | Welcome Remarks from Workshop Co-Chairs 09:30 | How We Got Here 09:55 | Case Study |
11:00 – 11:30 | Break in Exhibit Area
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11:30 – 12:45 | Small Group Activity In this session, participants will use the concepts and tools introduced in the previous session to begin drafting their own contamination control strategies. There will be ample time for discussion with their facilitator and peers. |
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11:30 | Activity Introduction 11:40 | Individual Work on Own Process 11:55 | Group Discussion |
12:45 – 13:45 | Networking Lunch
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13:45 – 15:25 | Rotating Stations Participants will rotate through four different stations, each led by SME facilitators, focusing on a key section of TR90. Upon joining each station, participants will select which sub-topic they would like to start the discussion with and then facilitators will guide the conversation through the rest of the topics. All participants will be randomly assigned to a group and will have the opportunity to rotate through all four stations (two station on Day 1 and two station on Day 2).
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13:45 | Activity Orientation 13:55 | Rotation 1 14:35 | Break and Station Switch 14:45 | Rotation 2 |
15:25 – 16:00 | Break in Exhibit Area
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16:00 – 17:00 | P2: Day 1 Report Outs and Q&A Day 1 will close out with a report out from and Q&A with the SME station facilitators. |
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16:00 | Station Report Outs 16:45 | Day 1 Wrap Up and Q&A |
17:00 – 18:00 | Reception in Exhibit Area
Day 2
THURSDAY, 02 MARCH
08:00 – 12:30 | Registration Open
08:00 – 09:00 | Continental Breakfast
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09:00 – 10:40 | Rotating Stations Participants will regroup and complete their station rotations that were started on the previous day. |
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09:00 | Welcome and Activity Reorientation 09:10 | Rotation 3 09:50 | Break and Station Switch 10:00 | Rotation 4 |
10:40 – 11:00 | Networking Refreshment Break
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11:00 – 12:30| P3: Day 2 Report Outs and Q&A The Workshop will close with a final report out from the SME station facilitators and a final opportunity for small group discussion. |
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11:00 | Station Report Outs 11:25 | Small Group Discussion 11:55 | Q&A and Wrap Up 12:15 | Closing Remarks from Workshop Co-ChairsBiswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi |
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Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Raleigh Convention Center
500 South Salisbury StreetRaleigh, NC ,
The Workshop will take place at the Raleigh Convention Center (500 S Salisbury Street). PDA does not have a block of hotel room, but recommends these nearby hotels: