PDA Education

PDA logo

The 2014 PDA Education Program featured fresh ideas and inspiring sessions produced by the PDA (Parenteral Drug Association). See below for the 2014 PDA Education Program content.

The 2015 PDA Education Program Schedule will be posted soon.

Tuesday Wednesday Thursday

Tuesday Schedule

As of 12/18/13. Subject to change.

Tuesday - March 18
10:30am – 10:45am Welcome and Opening Remarks
Richard M. Johnson, President, PDA
Location: 1E15 & 1E16
10:45am – 12:15pm

Session P1: Industry Trends and Regulatory Expectations
Moderator: Hal Baseman, Chief Operating Officer, ValSource, LLC.
Location: 1E15 & 1E16

Session schedule:
10:45am – 11:15 am:
Presentation: Regulatory Expectations – Pharmaceutical Manufacturing
Speaker: Richard L. Friedman, Associate Director, Office of Compliance, CDER, FDA

11:15am – 11:45am:
Presentation: Driving Manufacturing Excellence
Speaker: Michael Long, PhD, Director & Principal Consultant, ConcordiaValSource, LLC

11:45am – 12:15 pm:
Q&A/Discussion

12:15pm – 1:45pm PDA Education Program Lunch (Show Floor)
1:45pm – 3:15pm

Session P2: Biopharmaceutical and Sterile Manufacturing
Moderator: Maik Jornitz, Chief Operating Officer, G-Con Manufacturing LLC
Location: 1E15 & 1E16

Session schedule:
1:45pm – 2:15pm
Presentation: Aseptic Spray Drying – A Valid Alternative to Lyophilization
Speaker: Andrew P. Birkmire, Process Development Manager, GEA Process Engineering

2:15pm – 2:45pm
Presentation: When Secure Becomes Safe in Aseptic Processing – Single-Use Technologies as an Enabler
Speaker: Maurice Phelan, BioProcess Services Leader, GE Healthcare Life Sciences

2:45pm – 3:15pm
Q&A/Discussion

3:15pm – 3:30pm Break (PDA Education Program Area)
3:30pm – 5:00pm

Session P3: PDA Facilities/Engineering Interest Group Meeting
Moderator: Christopher Smalley, PhD, Director, BioSterile Validation, Merck & Co., Inc.
Location: 1E15 & 1E16

Session schedule:
3:30pm – 4:00pm
Presentation: Market Influence on Facility Design
Speaker: Matt Roberge, Senior Director, Global Supply, Pfizer, Inc.

4:00pm – 4:30pm
Presentation: Innovative Use of Isolators in Bulk Vaccine Product Handling
Speaker: David Moyle, Senior Specialist, Global Engineering Services, Merck & Co., Inc.

4:30pm – 5:00pm
Q&A/Discussion

Wednesday Schedule

As of 12/18/13. Subject to change.

Wednesday - March 19
10:30am – 12:00pm

Session P4: Prefilled Syringe/Drug Delivery Technology
Location: 1E15 & 1E16

Session schedule:
10:30am – 10:40am
Presentation: Challenges and Opportunities for the Prefilled Syringe /Drug Delivery Technology
Speaker: Michael F. Chiappetta, PhD, Research Advisor, DDR&D Advanced Development, Eli Lilly and Company

10:40am – 11:00am
Presentation: Improvements in needle Technology for Prefilled Syringes
Speaker: Kevin Constable, Director of Technology Development, Terumo Medical Corporation

11:00am-11:20am
Presentation: Next generation of Plastic Syringes and Lubricants
Speaker: Kevin Turney, PhD Senior Application Development Scientist, SiO2 Medical Products

11:20am-11:40am
Presentation: Novel Approaches to Flexible Syringe Filling Lines
Speaker: Wenzel Novak, PhD, Director of Pharmaceutical R&D, Groninger & co. gmbh

11:40am – 12:00pm
Q&A/Discussion

12:00pm – 1:30pm

PDA Education Program Lunch (Show Floor)

1:30pm – 3:00pm

Session P5: Supply Chain for the 21st Century
Moderator: E.J. Brandreth, Senior Vice President, Quality and Regulatory Affairs, Althea
Location: 1E15 & 1E16

Session schedule:
1:30pm – 2:00pm
Presentation: Innovation and Risk Management, Multi-Product Operations in Biotechnology
Speaker: Michael Blackton, AVP Validation Technical Services, Imclone Systems

2:00pm – 2:30pm
Presentation: Patients are Counting on Us: It’s Time to Act
Speaker: Brian Johnson, Senior Director, Supply Chain Security, Pfizer, Inc.

2:30pm – 3:00pm
Q&A/Discussion

3:00pm – 3:15pm

Break (PDA Education Program Area)

3:15pm – 4:45pm

Session P6: Parenteral Packaging
Moderator: Ronald G. Iacocca, PhD, Senior Engineering Advisor Drug Delivery/Device R&D, Eli Lilly and Company
Location: 1E15 & 1E16

Session schedule:
3:15pm – 3:45pm
Presentation: Container Closure Strategies for Parenteral Products, and the New Techniques that are Available
Speaker: Akshay R. Kamdar, Ph.D., Senior Consultant Engineer, Packaging Development, Packaging and Device Design and Development, Eli Lilly and Company

3:45pm – 4:15pm
Presentation: Ez-Ecopak and Equipment Fill-Finish Lines
Speaker: Paolo Golfetto, Business Development & Customer Care Director, Nuova OMPI, Stevanato Group

4:15pm – 4:45pm
Q&A/Discussion

Thursday Schedule

As of 12/18/13. Subject to change.

Thursday - March 20
10:30am – 12:00pm

Session P7: PDA Pharmaceutical Water Interest Group Meeting
Moderator: Igor Gorsky, Senior Consultant, ConcordiaValSource, LLC
Location: 1E15 & 1E16

Session schedule:
10:30am – 11:00am
Presentation: Monitoring and Continued Verification of Water Systems, Application of Lifecycle Approach
Speaker: Igor Gorsky, Senior Consultant, ConcordiaValSource, LLC

11:00am – 11:30am
Presentation: Ultrapure Water – Quality and Technology to Support Advanced Industries’ Needs
Speaker: Vyacheslav (Slava) Libman, Water Lab Director, Air Liquide-Balazs Nanoanalsis

11:30am – 12:00pm
Q&A/Discussion on New Trends in Pharmaceutical Water Systems's

12:00pm – 12:30pm

PDA Education Program Lunch (Show Floor)

12:30pm – 3:00pm

Session P8: Closing Plenary-Aging Facilities
Moderator: Richard M. Johnson, President, PDA
Location: 1E15 & 1E16

Session schedule:
1:45pm – 2:15pm
Presentation: PDA Aging Facility Task Force – Scope, Deliverables and Up-date
Speaker: Maik Jornitz, Chief Operating Officer, G-Con Manufacturing LLC

2:15pm – 2:45pm
Presentation: Aging Facilities: Are They Being Asked to Do Something More or Different Than Designed For?
Speaker: Christopher Smalley, PhD, Director, BioSterile Validation, Merck & Co., Inc.

2:45pm – 3:00pm
Q&A/Discussion

3:00pm

Closing Remarks
Richard M. Johnson, President, PDA

About PDA

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its nearly 10,000 members worldwide. For information, visit www.pda.org and follow PDA on LinkedIn.

Advertisement
Advertisement

Press Releases

We use cookies to operate this website and to improve its usability. Full details of what cookies are, why we use them and how you can manage them can be found by reading our Privacy & Cookies page. Please note that by using this site you are consenting to the use of cookies.