Science and Risk-Based Validation: Using Practical Approaches Across Projects to Break Down Implementation Silos (E05)

9-10 June CEUs: 1.2

Sponsored by the SPP, C&Q, CU, and HVAC Communities of Practice.

Science- and risk-based approaches to qualification and validation, introduced with ICH Q9, have been with us for several years now. The promise of more flexible facilities and processes entices, but how do you apply these concepts successfully on your project? This seminar will examine the latest developments and practical examples of application of science- and risk-based approaches in the qualification of a new greenfield aseptic fill and packaging site, as well as in cleaning, sterility, pharmaceutical water systems, and clean-room HVAC applications. Hear from the FDA how science and risk based approaches are incorporated in the new FDA how science- and risk-based approaches are incorporated in the new FDA Guidance on Process Validation. Ask questions, participate in interactive workshops, learn and bank the experiences of our presenters and your colleagues to streamline and customize your projects and your company challenges.

How You Will Benefit

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

Apply effective science- and risk-based validation approaches across applications
Understand the implications of the new FDA Guidance at your company
Analyze how separate entities at your company could work together to streamline your company’s validation challenges
Interpret protocols to understand the outcome needed

Who Should Attend

Validation professionals, development engineers, process engineers, QA and QC professionals, automation engineers, project managers

Leaders

Mark Hannon, Principal Technical Manager, Genentech, USA
Nicholas Haycocks, Senior QA Associate, Amgen, USA

Speakers

Catherine Acosta, Operational Excellence Senior Manager, Genentech, USA
Janet Bowen, Dir Compliance/Quality Sys, Commissioning Agents, Inc, USA
Ronald Brunelle, Director Quality Assurance, Amgen Inc, USA
Penelope Butterell, Senior Validation Manager, Pfizer, Belgium
Mark Foss, Managing Director, Sciurus Consultancy, United Kingdom
Francis Godwin, Compliance Officer, FDA, USA
Tara Gooen, LT, PHS, Team Leader, FDA/CDER/DMPQ, USA
Timothy Howard, CPIP, PE, Director, Commissioning/Validation, Commissioning Agents, Inc., USA
Laura Klewer, Senior Engineer, Amgen Inc, USA
James Lambert, Director, Quality Engineering, Genentech, USA
David Selby, PhD, Managing Director, Selby Hope International Ltd, United Kingdom
Stephen Shanks, Project Engineer, Genentech, USA
Corey Veverka, Manager of Projects, Total Validation Services Inc, USA
Kathleen Waters, Principal Engineer, Genentech, USA
Peter Watler, PhD, Principal Consultant, Hyde Engineering + Consulting Inc, USA
Stephanie Wilkins, PE, President, PharmaConsult US Inc, USA
Gary Zoccolante, Pharma Tech Director, Siemens Water Technologies Corp, USA

Communities of Practice (COPs)

C&Q
HVAC
OSD
Sterile Products Processing
Biotech
Critical Utilities
Investigational Products
Product Process Development

Knowledge Elements

1 - Product Development
- B. Technology transfer
- C. Production scale-up and optimization
2 - Facilities and equipment
- B. Commissioning and qualification as a risk management strategy
- D. Controls and automation
5 - Production systems
- A. Production unit operations - drug (small molecule) and biologics
6 - Regulatory compliance (includes drugs, environmental, health and safety)
- A. Government regulations
- B. Standards, practices, and guides
7 - Quality systems
- B. Systems validation (changed from Validated Controls)

Related Technical Docs and/or PE, JPI article

Webinars on Process Validation found at www.ISPE.org/OnlineLearning
Check on articles in PE, esp. Nov/Dec issue PE
ASTM E2500

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.