Designing Approaches to Pharma Facility & Lifecycle Management

The 2017 ISPE/FDA/PQRI Quality Manufacturing Conference offers a new and exciting format where participants will be able to interact directly with pharmaceutical industry and regulatory leaders in a four-series workshop rotation.  Today’s blog focuses on Designing Proactive Approaches to Pharmaceutical Facility and Lifecycle Quality Management, one of four core workshops taking place at the conference. Operation and maintenance of a compliant and robust pharmaceutical facility day to day is complex.  Facility systems, utilities, equipment, qualifications, and preventive maintenance processes have a large impact on the quality and robustness of the finished product.  A holistic lifecycle approach to process and facility maintenance will help prevent drug shortages, costly recalls, etc. This session will discuss state of the art best practices for operating a facility, its systems, and equipment.   This session will also allow you to hear and share best practices in this area and how companies maintain their facilities and processes in a state of control. Objective of the Workshop:

• Share and debate best industry practices for holistic Lifecycle approaches for maintaining your facilities and processes in a state of control
• Explore optimal ways to assure your processes key parameters remain in a state of control (i.e. process monitoring capability and control, continuous process verification etc.
• To blend in quality, scientific and engineering aspects of your facility and processes

Facilitators:

• Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly & Co.
• James McGlade, Science Market Leader, BHDP Architecture
• Rakhi Shah, PhD, Branch Chief (Acting), Office of Process & Facilities, FDA/CDER/OPQ

Tired of listening to talk after talk?  Learn why the 2017 IPSE/FDA/PQRI Quality Manufacturing Conference will be unlike any pharmaceutical industry conference you’ve experienced before!

2017 ISPE/FDA/PQRI Quality Manufacturing Conference The 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference offers you the unique opportunity to interact directly with industry and regulatory leaders to identify real solutions to your organization’s challenges on key issues. Sessions are designed to encourage open discussion about current FDA priorities and industry-critical quality initiatives.