ISPE Brussels Conference 2010 Risk-MaPP

Dedicated Facilities, Cross Contamination and the Risk-MaPP Approach

Monday 20 - Tuesday 21 September

Seminar Leaders:
Stephanie A. Wilkins, PharmaConsult US, Inc (USA);
Nigel Hamilton, Sanofi Aventis (UK)

As manufacturers are looking to reduce cost and increase efficiency, more multi-product facilities are being utilised either directly by the manufacturers or through partnerships with contract manufacturing organisations (CMOs).
With the use of multi-product facilities, the risk of cross contamination increases. By properly managing the risk of cross contamination manufacturers can reap the benefit of lower cost and higher efficiency while maintaining product quality and patient safety.

The much anticipated release of ISPE’s new Risk-MaPP Baseline® Guide provides a scientific risk-based methodology based on ICH Q9 to manage the risk of cross contamination.

A series of workshops and case studies led by the Guide authors will focus on use of the logic diagramme, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulating a Quality Risk Management Plan as part of a Quality System. Basic and background information will be provided via webinar prior to the conference so that more time can be spent on workshops and case studies.

Upon registration, a copy of the guide will be sent to you (after anticipated publication during third quarter 2010) so that you can get familiar with the document prior to the workshops; please bring your copy to the seminar. Note that if you cancel your attendance, you will be charged for the document plus shipping.


Day 1, Monday 20 September

10.20 – 11.05 Using Risk-MAPP through the product lifecycle
Nigel Hamilton, Sanofi-Aventis (UK)

  • Risk Management for Product and Process Development
  • Risk Management for Tech Transfer
  • Risk Management for qualification, validation and continuous verification
  • Risk Management for continuous improvement and end of lifecycle

11.05 – 12.15 Using the Logic Diagram and the IH and GMP Balance
Paul Wreglesworth, Independent Consultant, Formerly AstraZeneca (UK)

  • Introduction to the Logic Diagram and how to use it
  • Balancing IH and GMP needs
  • Introduction of a new compound into the facility

12.15 – 13.00 Lunch

13.00 – 14.30 Setting Limits
Bruce Naumann, Merck (USA)

  • Risk Identification with workshop on reviewing MSDS’(Material Safety Data Sheets), package inserts and internet resources
  • Derivation of Acceptable Daily Exposures (ADEs)
  • Addressing compounds with difficult endpoints
  • Workshop on setting ADEs
  • Setting Health-Based Safety Thresholds/Acceptance Limits

14.30 – 15.30 OsoBio Case Study
Kim Ray Oso Biopharmaceuticals (USA)

  • Incorporation of Risk-MaPP principles into Oso’s operation
  • Effect of Risk-MaPP on Oso’s interactions with clients
  • Reaction of global regulatory bodies to the QRMP

15.30 – 15.45 Break and networking exhibition

15.45 – 15.55 Using the Logic Diagram – Part 2
Paul Wreglesworth, Independent Consultant, Formerly AstraZeneca (UK)

  • Introduction of a new compound into the facility

15.55 – 17.30 Cleaning
Rich Forsyth, Hyde Engineering (USA)

Discussion on Design of Experiments to assist with cleaning validation

  • Discussion on Design of Experiments to assist with cleaning validation
  • Workshop on the apparent safety margin and how to set cleaning validation limits
  • Workshop on visually clean

17.30 – 17.45 Questions and Answers, Close of Day 1
Stephanie Wilkins, PharmaConsult Us, Inc (USA); Nigel Hamilton, sanofi-aventis (UK)

17.45 – 18.45 Exhibition Networking Reception


Day 2, Tuesday 21 September

09.00 – 09.10 Review of Day 1, Introduction of Day 2
Stephanie Wilkins, PharmaConsult Us, Inc (USA)

09.10 – 09.20 Using the Logic Diagram – Part 3
Paul Wreglesworth, Independent Consultant, Formerly AstraZeneca (UK)

  • Factors other than cleaning

09.20 – 10.50 Risk Analysis/ Control
Julian Wilkins PharmaConsult Us, Inc (USA)

  • Review of Risk Analysis and Risk Management Tools
  • Workshop on use of Risk Management Tools to analyze risk of cross contamination
  • Review of methods to reduce/ control risk
  • Workshop on risk control

10.50 – 11.05 Break and networking exhibition

11.05 – 12.05 How to Incorporate Risk-MaPP into Quality Systems
Jeff Campie, Aexelon Therapeutics (USA)

  • How Risk-MaPP fits into the quality system?
  • Workshop on incorporating Risk-MaPP principles into the Quality System (developing/ enhancing governance documents)

12.05 – 13.30 Pulling it All together
Stephanie Wilkins, PharmaConsult Us, Inc (USA)

  • Structuring the QRMP document
  • Preparation of a Quality Risk Management Plan summarizing the tasks from all the workshops
  • Presentation of “QRMPs” to the group

13.30 – 14.15 Lunch

14.15 – 15.15 élan Case Study
Mark O’Reilly, Aisling Horan, élan (Ireland)

  • Integration of Risk-MaPP principles into élan’s operations
  • The impact of Risk-MaPP on operations
  • Challenges and Lessons Learned

15.15 – 16.00 EMA Status on Dedicated Facilities and Risk-MaPP
Catherine Lefebvre, AFSSAPS (France)

  • Update on status of EMA dedicated facilities revisions
  • Lessons from the field
  • The best way to apply Risk-MaPP from a regulatory point of view

16.00 – 16.15 Questions and Answers, Close of Seminar
Stephanie Wilkins, PharmaConsult Us, Inc (USA)