2023 PDA Contamination Control Strategy Workshop (New Orleans)
Registration Options
Individual Registration
Group Registration
Program Highlights
Make sure to save your seat – the first offering of this workshop was sold out!
All Workshop participants will receive an electronic copy of the new PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR 90)!
Join us in New Orleans 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
- Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi and Workshop Chair
- Frederic B. Ayers, Research Scientist, Eli Lilly and Company
- Marcia C. Baroni, MBA, VP Enterprise GxP Compliance & Systems, Emergent BioSolutions
- Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
- Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.
- 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.
- Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb
- Nidhi Shah, MBA, Director Aseptic Process SME FFIP, Sanofi
- 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
THURSDAY, 06 APRIL
08:00 – 17:30 | Registration Open
08:00 – 09:15 | Continental Breakfast
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09:15 – 10:45 | P1:Developing a Contamination Control Strategy Workshop In this 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 and TR Introduction 09:50 | QRM as a Foundation to CCS |
10:45 – 11:15 | Break in Exhibit Area
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11:15 – 12:30 | Small Group Breakout In this session, participants will use a hands-on tool to begin evaluating their own contamination control strategies. There will be ample time for discussion with their facilitator and peers. Each topic will open with a short overview of considerations from the TR, then time for individual evaluations followed by table discussion. |
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11:15 | Introduction to the Breakout Activity 11:35 | TR90 Overview: Personnel/Training 11:45 | Individual Work 11:55 | Breakout Discussion |
12:30 – 13:30 | Networking Lunch
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13:30 – 14:45 | Small Group Breakout In this session, participants will use a hands-on tool to begin evaluating their own contamination control strategies. There will be ample time for discussion with their facilitator and peers. |
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13:30 | TR90 Overview: Process Design 13:40 | Individual Work 13:50 | TR90 Overview: Vendor/Material 14:00 | Individual Work |
14:45 – 15:15 | Break in Exhibit Area
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15:15 – 16:30 | 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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15:15 | Activity Orientation 15:25 | Rotation 1
15:55 | Station Switch 16:00 | Rotation 2
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16:30 – 17:00 | P2: Day 1 Report Outs and Q&A Day 1 will close out with a Q&A Panel with the day's presenters |
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16:30 | Q&A and Wrap Up |
17:00 – 18:00 | Reception in Exhibit Area
Day 2
FRIDAY, 07 APRIL
07:00 – 12:30 | Registration Open
07:00 – 08:00 | Continental Breakfast
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08:00 – 08:45 | P3: Creating a CCS Document This interactive session will cover the CCS structure proposed in TR90 and give some practical guidance on how to structure the CCS document hierarchy for multi-product facilities. |
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08:00 | Creating a CCS Document and CCS Lifecycle Management 08:25 | Q&A |
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08:45 – 10:00 | Small Group Breakout In this session, participants will use a hands-on tool to begin evaluating their own contamination control strategies. There will be ample time for discussion with their facilitator and peers. |
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08:45 | TR90 Overview: Equipment/Barrier Tech 08:55 | Individual Work on Own 09:05 | TR90 Overview: Facility/Utility 09:15 | Individual Work on Own 09:25 | Group Discussion |
10:00 – 10:20 | Break
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10:20 – 11:35 | 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. |
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10:20 | Welcome Back and Activity Reorientation 10:30 | Rotation 3
11:00 | Station Switch 11:05 | Rotation 4
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11:35 – 12:30| P4: 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 questions from attendees. |
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11:35 | Station Report Outs 11:55 | Q&A and Panel Discussion with Station Leads 12:25 | Closing Remarks from Workshop Co-Chairs |
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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.
Rate: $255 USD for single/double occupancy, plus state and local taxes
Cut-Off Date: Friday, 03 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
Check-In: 16:00
Check-Out: 11:00
Reservations
Online: Click on the reservation link above
Phone: +1 (504) 561-1234, make sure to give the PDA Group Code, G-PDAA, to receive the discounted conference rate
Individual Cancellation
72 hours prior to 23:59 local time of the day of arrival to check-in to avoid one night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.
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