ISPE Technical Conferences

12 – 15 September | Conference | Maryland, US

The International Society for Pharmaceutical Engineering (ISPE) will host its 2017 Process Validation and Process Validation Statistics Conferences in Bethesda, Maryland.

These concurrent events offer comprehensive solutions to process validation lifecycle challenges faced by process validation professionals and statisticians today.

John Bournas, CEO and President at ISPE, said: “These conferences are invaluable due to the breadth of process validation lifecycle challenges addressed and the opportunity to interact with experienced and leading practitioners and regulatory experts.”

Designed to expand attendee knowledge of the many facets of process validation, these back to back events cover the entire Process Validation Lifecycle — from Stage 1 Process Design through to Stage 3 Continued Process Verification (CPV).

Benchmarking opportunities are numerous through shared real world experiences of successes and challenges from presenters and fellow professionals.

Process Validation Conference | 12 – 14 September

Keynotes:

• Zhihou 'Peter' Qui, PhD, Branch Chief, Division of Inspectional Assessment, FDA/OPF/OPQ/CDE
• Ranjani Prabhakara, PhD, Team Leader, Office of Compliance, Division of Drug Quality II, FDA/CDER/OMQ

Featured FDA Sessions:

• FDA Perspective on Process Validation for Biotech Products
• Stage 3 Process Validation and Quality Risk Management Procedures: ICH Q9

Process Validation Statistics Conference | 13 – 15 September

Keynote:

• Kit Roes, PhD, Professor of Clinical Trial Methodology, University Medical Center Utrecht and Observer in the EMA Biostatistics Working Party

Featured FDA Sessions:

• Application of Statistics in the Process Validation Lifecyle
• Considerations for Continuous Manufacturing Implementation throughout a Product Lifecycle: FDA Perspective

Attendees of both conferences will have access to two concurrent evening sessions, a half day regulatory session, a networking reception, and a registration discount.

Event venue: Bethesda Marriott

Organiser: ISPE

Tel: +1 301 364 9207

Email: mrobertson@ispe.org

Web: www.ispe.org/2017-process-validation-conference | www.ispe.org/2017-process-validation-statistics-conference

Companies

• International Society for Pharmaceutical Engineering