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2023 Contamination Control Strategy Workshop

2023 PDA Contamination Control Strategy Workshop (New Orleans)

Apr 06 - Apr 07, 2023
New Orleans, LA

  • Workshop
  • The Americas
Closed
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)!

Overview

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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Agenda

  • Day 1
  • Day 2

  • THURSDAY, 06 APRIL

    08:00 – 17:30 | Registration Open

    08:00 – 09:15 | Continental Breakfast

    09:15 – 10:45 | P1:Developing a Contamination Control Strategy Workshop
    Moderator: Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK

    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.

    09:15 | Welcome Remarks from Workshop Co-Chairs and TR Introduction
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi
    Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK

    09:50 | QRM as a Foundation to CCS
    Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

    10:10 | CCS Case Study
    Cheryl E. Essex, MS,     Head of Quality Operations R&D Genomic Medicines, Sanofi

    10:30 | Q&A

    10:45 – 11:15 | Break in Exhibit Area

    11:15 – 12:30 | Small Group Breakout
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    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.

    11:15 | Introduction to the Breakout Activity
    Madison Hoal, Global Technical Consultant, Ecolab Life Sciences

    11:35 | TR90 Overview: Personnel/Training
    Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.

    11:45 | Individual Work

    11:55 | Breakout Discussion

    12:30 – 13:30 | Networking Lunch

    13:30 – 14:45 | Small Group Breakout
    Moderator: Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK

    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.

    13:30 | TR90 Overview: Process Design
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    13:40 | Individual Work

    13:50 | TR90 Overview: Vendor/Material
    Chris Knutsen, PhD,     Technical Fellow, Microbiology, Bristol Myers Squibb

    14:00 | Individual Work

    14:10 | Group Discussion

    14:45 – 15:15 | Break in Exhibit Area

    15:15 – 16:30 | Rotating Stations
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    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).

    • Station 1: Facility/Utility (topics include environmental monitoring performance qualification, environmental monitoring, maintenance, utility, start-up, facility flow, validation, etc.)
    • Station 2: Raw Material/Process (topics include opening processing, viral risk, in-process testing strategy, advanced therapy medicinal products (ATMPs), container closure integrity testing (CCIT), aseptic process simulation (e.g., media fills, etc.)
    • Station 3: Personnel/Training (topics include awareness, culture, governance, training/qualification, gowning, aseptic process simulation (“media fills”), etc.)
    • Station 4: Equipment/Barrier Technologies (topics include cleaning validation, gloves, barrier technologies, single-use technologies, robotics, etc.)

    15:15 | Activity Orientation
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    15:25 | Rotation 1

    • Group A – Station 1
    • Group B – Station 2
    • Group C – Station 3
    • Group D – Station 4

    15:55 | Station Switch

    16:00 | Rotation 2

    • Group A – Station 2
    • Group B – Station 1
    • Group C – Station 4
    • Group D – Station 3

    16:30 – 17:00 | P2: Day 1 Report Outs and Q&A
    Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

    Day 1 will close out with a Q&A Panel with the day's presenters

    16:30 | Q&A and Wrap Up
    Frederic B. Ayers,     Research Scientist, Eli Lilly and Company
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi
    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
    Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK

    17:00 – 18:00 | Reception in Exhibit Area

  • FRIDAY, 07 APRIL

    07:00 – 12:30 | Registration Open

    07:00 – 08:00 | Continental Breakfast

    08:00 – 08:45 | P3: Creating a CCS Document
    Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    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.  

    08:00 | Creating a CCS Document and CCS Lifecycle Management
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    08:25 | Q&A

    08:45 – 10:00 | Small Group Breakout
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    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. 

    08:45 | TR90 Overview: Equipment/Barrier Tech
    Patrick Mains, Senior Consultant, ValSource, Inc

    08:55 | Individual Work on Own

    09:05 | TR90 Overview: Facility/Utility
    Donald C. Singer, MA, ASQ Fellow, CPGP, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    09:15 | Individual Work on Own

    09:25 | Group Discussion

    10:00 – 10:20 | Break

    10:20 – 11:35 | Rotating Stations
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    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.

    10:20 | Welcome Back and Activity Reorientation
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    10:30 | Rotation 3

    • Group A – Station 3
    • Group B – Station 4
    • Group C – Station 1
    • Group D – Station 2

    11:00 | Station Switch

    11:05 | Rotation 4

    • Group A – Station 4
    • Group B – Station 3
    • Group C – Station 2
    • Group D – Station 1

    11:35 – 12:30| P4: Day 2 Report Outs and Q&A
    Moderator: Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK

    The Workshop will close with a final report out from the SME station facilitators and a final opportunity for questions from attendees.  

    11:35 | Station Report Outs

    11:55 | Q&A and Panel Discussion with Station Leads

    12:25 | Closing Remarks from Workshop Co-Chairs
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi
    Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK

Networking Opportunities

THURSDAY, 06 APRIL

  • 11:00 – 11:30 | Refreshment Break in Exhibit Area
  • 12:45 – 13:45 | Networking Lunch
  • 15:25 – 16:00 | Refreshment Break in Exhibit Area
  • 17:00 – 18:00 | Reception in Exhibit Exhibit Area

FRIDAY, 07 APRIL

  • 10:40 – 11:00 | Refreshment Break

Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
ValSource, Inc.
Marcia C. Baroni
Marcia C. Baroni
Emergent BioSolutions
Richard Denk
Richard Denk
SKAN AG
Cheryl E. Essex
Cheryl E. Essex
Sanofi
Marc Glogovsky
Marc Glogovsky
ValSource, Inc.
Madison Hoal
Madison Hoal
Ecolab Life Sciences
Chris Knutsen
Chris Knutsen
Bristol-Myers Squibb
Patrick Mains
Patrick Mains
ValSource Inc.
Amanda McFarland
Amanda McFarland
ValSource, Inc.
Christopher A. Murdock
Christopher A. Murdock
Bristol Myers Squibb
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences
Kim R. Sobien
Kim R. Sobien
ValSource, Inc.

Additional Information

  • Who Should Attend

    More information coming soon.

Got a Question? We have answers

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Travel

PLEASE 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.

Hyatt Regency New Orleans

601 Loyola Avenue
New Orleans, LA

Make a Reservation
Hyatt Regency New Orleans
  • Accommodations
    The 2023 PDA Contamination Control Strategy Workshop will take place at the Hyatt Regency New Orleans!

    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.

  • Amenities

    Discover the culture of the Crescent City at Hyatt Regency New Orleans. Centered downtown near Champions Square, Smoothie King Center, and minutes from the historic Mississippi Riverfront. There's no better place from which to explore the eclectic vibrancy of New Orleans.

    Hyatt Regency New Orleans is conveniently located near many popular attractions. They’re only a few minutes walk from the French Quarter and the Arts District. Or hop on the city’s famous streetcars — the Loyola line stops directly outside the hotel.

How to Get Here

By Air

Louis Armstrong New Orleans International Airport (MSY) is approximately 15 miles (24km) from the hotel and all major carriers service this airport. Taxi fares from MSY are approximately $36 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency New Orleans is located at 601 Loyola Avenue, New Orleans, LA 70113. Valet parking is offered at the hotel and there are several nearby parking lots, including the 1301 Girod Parking Garage that connects directly to the hotel. Contact Merit Parking to confirm pricing; +1 (504) 561-0575.

Other Options

Hyatt Regency New Orleans is happy to partner with a local shuttle service to make your trip to and from the Louis Armstrong New Orleans International Airport easy. To learn more, and reserve your spot at least 24 hours prior to your flight arrival time, visit airportshuttleneworleans.com/portals/hyatt-regency-new-orleans.

Directions

Registration Fees

Early Registration
REGISTRATION TYPE BY 05 FEBRUARY
Member $1,595
Non-Member $1,995
Gov./Health Authority/Academic (Member Only) $795
Early Career Professional (Member Only) $1,295
Student (Member Only) $495
Regular Registration
REGISTRATION TYPE AFTER 05 FEBRUARY
Member $2,095
Non-Member $2,495
Gov./Health Authority/Academic (Member Only) $895
Early Career Professional (Member Only) $1,395
Student (Member Only) $595

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].

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