PQRI PODP Extractables & Leachables Workshop

Presentations

Speaker Bios

Final Program

Day 1 – Wednesday, April 18, 2018

8:00 am

Registration and Continental Breakfast

Session A Moderator: Desmond G. Hunt, Ph.D. (United States Pharmacopeia (USP))

8:15 am

Welcome and Opening

Desmond G. Hunt, Ph.D. (USP)

8:30 am

I. Introduction to PODP Recommendation: Risk Based Concepts

Diane Paskiet, MS (West Pharmaceutical Services)

9:00 am

II. Derivation of Parenteral Safety Concern Thresholds (SCT)

Douglas J. Ball, MS, DABT (Toxicology Consultant)

9:30 am

III. Derivation and Validation of Parenteral Classification Strategy

Tim J. McGovern, Ph.D. (U.S. Food & Drug Administration)

10:00 am

Q&A Panel

10:30 am

Break

Session B Moderator: James Castner Ph.D., (Pharma Interface Analysis LLC)

11:00 am

IV. Best Practices Generating Extractable Profiles

Dennis R. Jenke, Ph.D. (Triad Scientific Solutions, LLC)

11:30 am

V. Analytical Technologies and Compound Identification

Daniel Norwood, Ph.D. (SCIO Analytical, LLC)

12:00 pm

Q&A Panel

12:30

LUNCH

Session C Moderator: Alan Hendricker, Ph.D. (Becton Dickinson)

1:30 pm

VI. Component Characterization: Sources of Potential Leachables

Michael Ruberto, Ph,D. (Material Needs Consulting)

2:00 pm

VII. The Analytical Evaluation Threshold: Derivation and Use

Thomas Feinberg, Ph.D. (SCIO Analytical)

2:30 pm

Q&A Panel

3:00 pm

Break

Session D Moderator: Christopher T. Houston, Ph.D. (Bausch + Lomb / Valeant Pharmaceuticals)

3:15 pm	VIII. The Simulation Study in Action – Establishing a Design Space for Terminally Sterilized Aqueous Drug Products in a Plastic Packaging System Dennis R. Jenke, Ph.D. (Triad Scientific Solutions, LLC)
3:45 pm	IX. Biologic Quality and Compatibility Considerations Diane Paskiet, MS (West Pharmaceutical Services)
4:30 pm	Q&A Panel
5:00 pm	Close of Day 1
5:30 – 7:30 pm	Networking Reception Hilton Rockville – Potomac Foyer 1750 Rockville Pike I Rockville MD 20852

Day 2 – Thursday, April 19, 2018
8:00 am	Continental Breakfast
*Session E Moderator: Desmond G. Hunt, Ph.D. (USP)*
8:15 am	I. Experimental Design Considerations for Ophthalmic Drug Products (ODP) a. Chemistry: Christopher T. Houston, Ph.D. (Bausch + Lomb / Valeant Pharmaceuticals) b. Toxicology: Mary E. Richardson, Ph.D. (iuvo BioScience)
9:15 am	Q&A Panel
9:30 AM	II. Application of Thresholds and Expectations: Regulatory Perspectives a. US Perspective: Timothy W. Robison, Ph.D. (US Food & Drug Administration) b. Japan Perspective: Validation of the Toxicological Threshold for E&L from the Single Use System Akihiko Hirose, Ph.D. (National Institute of Health Sciences (NIHS))
10:30 am	Q&A Panel
11:00 am	Break
Session F Moderator: Tim J. McGovern, Ph.D. (FDA)
11:15 am	III. Application of Thresholds Concept Applied to Container Closure System for a Parenteral Drug Products Leachable Evaluation of a Container Closure System – What to do When Above the Threshold William (Bill) P. Beierschmitt, Ph.D. (Pfizer Worldwide Research and Development)
11:45 am	Q&A Panel
12:00 pm	Lunch
1:00 pm	IV. Case Study Break Outs a. Small Volume Parenterals: Dan Mellon, Ph.D., (FDA), Jim Castner, Ph.D. (Pharma Interface Analysis LLC) b. Large Volume Parenterals: Tom Feinberg, Ph.D. (SCIO Analytical), Tim Robison, Ph.D. (FDA) c. Prefilled Syringes: Tim McGovern, Ph.D. (FDA), Alan Hendricker. Ph.D. (BD) d. Ophthalmic Drug Products: Chris Houston, Ph.D. (Bausch + Lomb/Valeant Pharmaceuticals), Desmond Hunt, Ph.D. (USP)
3:00 pm	Break
3:45 pm	V. Report out from Breakouts and Discussion Dan Mellon, Tom Feinberg, Tim McGovern and Chris Houston
4:15 pm	VI. Potential for New USP Chapter and Other Revisions Desmond G. Hunt, Ph.D. (USP)
4:30 pm	VII. Wrap Up and Close of Workshop

PQRI PODP E&L Workshop Presentations

PQRI PODP Extractables & Leachables Workshop

Presentations