Science and Risk-based Commissioning and Qualification (C&Q): Transitioning and Transforming

Wednesday 22 September - Thursday 23 September

Seminar Content Level: Advanced

Seminar leaders: Gert Mølgaard, NNE Pharmaplan, Denmark; Joerg Block, Bayer Healthcare (Germany)

Outlining science and 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: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment.

The two-day seminar will outline science and risk-based methodologies for planning and implementing a project through the entire life
cycle. It 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 company’s needs (efficient use of GEP 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, and building confidence in the process 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 available in advance of the seminar at no additional charge, so that you can better take advantage of this intermediate to advanced seminar.

Take Back to Your Job:

  • 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 organisation based on knowledge obtained through case studies and workshops
  • Understand regulatory perspectives and expectations
  • Analyse 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 practitioners, engineers, project managers, construction managers, and quality managers who need to understand and follow GEPs in order to design and deliver projects utilising risk-based approaches.

Communities of Practice (COPs):

C&Q, GAMP, Project Management

Related Technical Documents:

  • 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
  • ICH Q9
  • EU GMP Guide, Annex 15
  • ASTM E2500-07



Day 1, Wednesday 22 September

10.00 – 10.15 Welcome and Introduction
Gert Mølgaard, NNE Pharmaplan (Denmark); Joerg Block, Bayer Healthcare (Germany)

10.15 – 11.15 Introduction to ISPE Engineering ISPE Baseline® 12 - Science and Risk-Based C&Q
Steve Wisniewski, IPS (USA) Chairman of ISPE C&Q Community of Practice Introduction to ISPE  Baseline®Guide 12

  • Background
  • Overview of the process
  • Content of ISPE  Baseline®Guide 12

11.15 – 12.45 Risk Assessment Methodologies and Workshop
Tim Howard, Commissioning Agents Inc (USA)

  • Application of risk management from conceptual design development to final design review
  • RA tools best suited to each step in the process
  • Leveraging output of RA for verification
  • Workshop on the application of tools and design high-risk areas

12.45 – 13.45 Lunch 

13.45 – 14.30 EU Regulatory Perspective on Risk-Based C&Q
Ian Thrussell, GMP Expert Inspector, MHRA, UK

  • European regulatory requirements
  • Verification in an Quality by Design environment
  • Update on European trends

14:30 – 15:15 FDA Regulatory Perspective on Risk-Based C&Q
Teleconference with Steve Hertz (FDA)

15.15 – 15.45 Break

15.45 – 16.30 "Construction Quality" - The Key to Commissioning, Qualification & Time-to-Market
Jay Lad, SPGL Ltd, UK (Formerly Skanska Pharmaceutical Group); Stig Bochman-Perdersen, GSK Biologicals (Belgium)

  • Why does it take the pharmaceutical industry longer to deliver capital projects?
  • What are the challenges from a construction/field execution perspective?
  • What can a clear C&Q/Verification strategy, underpinned with a good Construction Quality Management Programme, accomplish?

16.30 – 17.45 Johnson and Johnson: Case Study on Risk based approach to API containment
Machteld Deconinck, Johnson&Johnson (Belgium)

  • J&J Implementation of Science and Risk-based Qualification
  • Case study
  • Evaluation of benefit and challenges

17.45 – 18.45 Networking Reception


Day 2, Thursday 23 September

09.00 – 09.15 Review of Day 1, Introduction to Day 2
Gert Mølgaard, NNE Pharmaplan (Denmark); Joerg Block, Bayer Healthcare AG (Germany)

09.15 – 10.45 Application of Quality Risk Management (QRM) Principles to Assure Equipment Fitness for Use and Process Sustainability for Manufacturing Operations
Petter Gallon, AstraZeneca, Sweden

  • Practical application of Quality Risk Management
  • Quality by Design principles
  • Case example

10.45 – 11.15 Break

11.15 – 12.00 Application of ASTM E2500 Verification to a Holding Tank for Aseptic Manufacturing
Jan Slock, Pfizer (Belgium)

  • Pfizer’s ASTM E2500 implementation project
  • Case study - saving paper, time and money by applying ASTM E2500-based verification
  • Challenges and lessons learned

12.00 – 12.45 Partnering with Vendors: Bayer Health Care Global 2-D Matrix Programme - Standard Equipment Qualification Case
Joerg Block, Bayer Schering (Germany)

  • Coordinated equipment qualification approach for a global programme
  • Implementation of ASTM 2500 and GAMP® 5 concepts
  • Cooperation with vendor and integration of vendor documentation

12.45 – 13.45 Lunch

13.45 – 15.45 Workshop: Applying a Top Down Approach to Verification via Critical Aspects
Armen Nahabedian, Global Quality, Pfizer (USA) and Chris Appleby, Global Quality, Pfizer (Belgium)

  • The new science and risk-based approach to verification relies on identification of critical aspects for manufacturing systems. Via small group interactive exercises, this workshop will show how to develop critical aspects by starting from process and product requirements. A standard CIP system will be used to illustrate and apply the concepts.

15.45 – 16.15 Questions and Answers, Close of Seminar
Gert Mølgaard, NNE Pharmaplan (Denmark); Joerg Block, Bayer Healthcare (Germany)