Science and Risk-Based Commissioning and Qualification: Transitioning and Transforming (E03)

7-8 June CEUs: 1.2

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

Outlining risk-based methodologies for planning and implementing a project through the entire lifecycle, this seminar includes case studies and workshops to help you gain a working knowledge of the ISPE Baseline^® Guide, Vol. 12: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment. It is anticipated that the Guide will be provided either at the conference, or subsequently if publish date is delayed.

The seminar will outline risk based methodologies for planning and implementing a project through the entire life cycle. The two-day seminar will feature the newest concepts and exemplify their applications in a way that you can use in your company.

• How to incorporate Quality Risk Management (QRM) principles (e.g., QbD, risk assessments, control strategies, product/process knowledge, etc.) into C&Q activities and deliverables (e.g., requirements definition, design review, C&Q planning, verification, test and release)
• Real-world implementation of risk-based approaches to fit your companies needs (efficient use of commissioning data and vendor documentation based on identified risk factors)
• Managing and documenting engineering/project change
• Verification processes for demonstrating fit-for-intended use
• Understanding, defining, and assigning roles and responsibilities for a risk-based project

Come and participate in discussions with the guide writers, case study presenters, and your colleagues who also intend to implement this new approach. For those less experienced, an introductory webinar will be made available to you at no additional charge, upon request, so that you can better take advantage of this intermediate to advanced seminar.

How You Will Benefit

• At the conclusion of this session, participants will be able to:
• Understand and apply QRM principles to C&Q
• Deliver projects more efficiently using lean risk-based applications
• Understand how to apply risk-based principles within your organization based on knowledge obtained through case studies and workshops
• Understand regulatory perspectives and expectations
• Analyze applications through case studies and how this knowledge can be applied to your company
• Gain insights into problem solving by applying concepts in the Guide.

Who Should Attend

C&Q crosses over most pharma manufacturing professionals but will be especially important for Commissioning and Qualification (Validation) professionals as well as design GAMP practicioners, engineers, project managers, construction managers, and quality managers who need to understand and follow GEPs in order to design and deliver projects utilizing risk-based approaches

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

Communities of Practice (COPs)

• C&Q (C&Q is a cross-functional COP in that it applies to many subject matter areas that other ISPE COPs represent. As a result, consult the agenda to see which case study subject matter areas will be addressed in this seminar.)
• GAMP
• Project Management

www.ISPE.org/COPs

Knowledge Elements

• 2 - Facilities and equipment
  • A. Design and construction/installation
  • B. Commissioning and qualification as a risk management strategy
  • C. Operation and maintenance
  • D. Controls and automation
• 6 - Regulatory compliance (includes drugs, environmental, health and safety)
  • B. Standards, practices, and guides
• 7 - Quality systems
  • A. Risk management and Quality Management System (QMS)

Related Technical Docs and/or PE, JPI articles

• ISPE Baseline^® Guide: Volume 5 – Commissioning and Qualification
• ISPE Baseline^® Guide: Volume 12 -- Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
• ISPE Good Practice Guides
• ICH Q9
• EU GMP Guide, Annex 15
• ASTM E2500-07

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.