PDA Single Use Systems Workshop Session Recordings

Knowledge Enables Implementation - A Consensus Approach

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Non-member: $280

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Save $140 by purchasing the Single Use Systems Workshop and 2012 Annual Meeting recordings together for a discounted price of $420 member/$500 non-member. Purchase here.

Price of registration includes:

  • All six (6) recorded sessions from the 2012 Single Use Systems Workshop
  • Access to 15 downloadable presentation PDF handouts
  • Unlimited access to the recordings for 60 days from the day of purchase

Opening Plenary Session: Technical Report (TR) Overview

The first recorded session includes presentations by the co-chairs of the Single Use System Task Force describing the Technical Report document concept, structure and key themes.  The presentations on Section 3 describe the flexible approach for the Technical Report reader to utilize the decision process to establish a manufacturing strategy.

Presenters:

Robert Repetto, Senior Director, External Affairs, Pfizer, Inc
Morten Munk, Vice President, Business Development, CMC Biologics

Plenary Session 2: Section 6 Part 1 - Qualification

Qualification is a crucial concern in implementing Single Use Systems.  Certainly the concerns regarding extractables and leachables are a major part of the qualification. Because Single Use Systems are frequently received by the User sterilized and ready-to-use, Supplier Qualification is a decisive measure in the qualification process, and in presenting the Technical Report section on Supplier Qualification the roles and responsibilities of the Supplier and the User in the Qualification effort is discussed.

Presenters:

Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences
Paul Priebe, Director of Marketing, Sartorius Corporation
Duncan Low, PhD, Scientific Executive Director, Amgen, Inc.

Plenary Session 3: Section 4 - Technology

This recorded session discusses various single use technologies and their impact on end user projects. Highlighting how end users have approached single use systems, what advantages were obtained and what challenges are on the horizon for the industry.

Presenters:

Jeffrey Carter, PhD, Director, Filtration Research and Development, GE Healthcare
Marion Traverse, Project Engineer, NNE Pharmaplan
Russell Wong, PhD, Senior Engineer,Manufacturing Sciences, Bayer HealthCare, LLC.

Plenary Session 4: Section 7 - Implementation

A well-planned and thorough implantation plan is a key for successful implementation of SUS. This recorded session provides an overview of areas to be included in an implementation plan around the main themes of Stakeholder Management, Risk Management and Process Validation and Verification. Areas addressed include SUS strategy, scoping, User Requirements, environmental and safety considerations, materials management and supplier selection and qualification and the workflows involved.

Presenters:

Robert Repetto, Senior Director, External Affairs, Pfizer, Inc.
Robert Shaw, Technical Director, Ark Therapeutics
Andy Walker, PhD, Senior Director, Manufacturing, CMC Biologics

Plenary Session 5: Section 5 - Business Drivers

The business drivers for introducing SUS are varied and depend on process, products, market, facilities as well as the general business model applied. While business common drivers are greater flexibility, facility utilization and reduce capital and operating costs, different business models create drivers for different business models. This recorded session covers numerous business drivers and considerations for Single Use Systems implementation.

Presenters:

Paul Priebe, Director of Marketing, Sartorius Corporation
Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences
Christopher J. Smalley, PhD, Associate Director, Bio/Sterile Manufacturing, Merck and Company, Inc.

Plenary Session 6: Regulatory Issues Related to Single Use Systems

This recorded session provides a presentation highlighting the regulatory perspectives and concerns with the design, implementation and use of Single Use Systems. These key presenters participating in the panel discussion are section leads for the chapters in the draft PDA Technical Report.

Presenter:

Tor Graberg, Chair of PIC/s and Head of Inspection, Medical Products Agency (MPA)
Panelists:

Tor Graberg, Chair of PIC/s and Head of Inspection, Medical Products Agency (MPA)
Duncan Low, PhD, Scientific Executive Director, Amgen, Inc. 
Morten Munk, Vice President, Business Development, CMC Biologics A/S
Robert Repetto, Senior Director, External Affairs, Pfizer, Inc.

Contact

Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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