Biopharmaceutical Quality: Implementing PQS Elements (Q10)

Session 503
Regulatory Track

ICH’s Q10 Pharmaceutical Quality System (Q10) guidance, which compliments ICH guidance “Q8 Pharmaceutical Development” and “Q9 Quality Risk Management,” describes a model for an effective pharmaceutical quality system (PQS) that can be implemented throughout the different states of a product lifecycle.

Session Description

Learn practical examples from the just released ISPE PQLI Guide: Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System that provides real world strategies for implementing the change management recommendations of ICH Q10. Parts 1, 2, and 3 of the ISPE PQLI Guide Series describe the concepts and principles of QbD and the potential product lifecycle approaches to the change management system element of a PQS.

Participants will have the opportunity to hear from regulatory and industry experts on a variety of important manufacturing issues including (1) change control methods, (2) methods to proactively monitor product quality (QSMR) and report on product health issues to senior management, (3) sampling, (4) statistical methods, (5) relationship to Qbd for biotech products, (6) control strategy, (7) CAPA, and (8) process validation. Interactive Q and A and comments will be important feedback for the volunteers preparing the guides.

At the conclusion of this session, participants will be able to:

Understand the latest Quality Management principles applicable to manufacturing biopharmaceutical products
Understand the challenges in having consistent product quality and process
Understand the process for new products, having robust change control for continual improvement efforts, methods for continually monitoring and improving process performance
Understand the QbD concepts (with focus on biotech products and examples) needed to drive efficient global lifecycle management
Understand the process for new products, having robust change control for continual improvement efforts, methods for continually monitoring and improving process performance

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom

Who Should Attend

Manufacturing / Operations
- Drug Substance
- Drug Product
- Biotech
- Small Molecule
Service Providers
Suppliers
Regulators
Quality Professionals
- Site Quality Heads
- QA
- QC
- Complaints
- Investigations
- Quality Stewards
Technical Development
CMC
Regulatory Affairs

Communities of Practice Members that will Benefit

API
Biotechnology
C&Q
Containment
Critical Utilities
Disposables
Engineering Standards Benchmarking
Good Control Laboratory Practices
HVAC
Investigational Products
Operations Management
Oral Solid Dosage
Packaging
PQLI
Process Analytical Technology
Process/Product Development
Project Management
Sterile Products Processing
Sustainable Facilities

More information on ISPE's Communities of Practice