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					                    MANAGE YOUR COST
                IMPLEMENT RISK MANAGEMENT




Practical information and case studies on :

      Basic principles on risk management and relation to current regulatory
       requirements ICH Q8-Q9-Q10 and EU GMP annex 20
      Why risk based approach in pharma operation and benefits
      Different risk assessment methods ( PRA – FMEA – Ishikawa – HAZOP –
       HACCP – FTA – RR method ) and evaluation of their usage in different
       fields in pharma
      Integration of risk management into daily operation
      Case studies ( 5 ) of implementation of risk assessment in different major
       pharma plants




                              26 MAY 2009
                           (from 9:00 h to 17:15 h)




Location:        Chateau de Limelette
                 Rue Charles Dubois 87
                 B 1342 Limelette ( Wavre near to E411 )
                 Tel: 010/ 42 19 99
MANAGE YOUR COST-IMPLEMENT RISK MANAGEMENT
 8:30 - 9:00 Registration and coffee
 9:00 - 9:10 ISPE Belgium welcome and introduction to the topic of the day.
             ( ir.Jef De Clercq, Managing Director ESC and President ISPE Belgium)

 9:10 - 9:40 A quality point of view on risk management.
             ( Mr D. T’ Jampens, associate director QA compliance & Quality systems at UCB, Belgium )

 9:40-10:20 Risk management: the complete picture.
             ( Ing. R. Clonen,MBA,MRE director consultancy at MCS N.V. Antwerp.)

10:20-11:00 Case study: transition from commissioning and qualification to
            specification, design and verification.
             (Mrs M. Deconinck, manager commissioning&qualification at Janssen Pharmaceutica, Beerse)

11:00-11:20 Coffee break and networking
11:20-12:00 Reduction of commissioning and qualification cost through risk
            based verification
             ( Mr J. Slock, commissioning&qualification engineer at Pfizer Manufacturing, Puurs )

12:00-12:40 Project cost risk assessment: “ How does J & J handles project
            contingency.”
             ( Mr M. Lynch, director project controls at Johnson & Johnson, Beerse)

12:40-14:00 Lunch with networking opportunities
14:00-14:40 Case study: Efficient risk management for an HVAC installation.
             ( Mr V. Meyer, global account manager Siemens Building Technologies, Huizingen
              Mr L. Sinave, utilities and facilities project engineer at Baxter, Lessines )

14:40-15:30 Case study: cross contamination in a multiple purpose facility
            Integrating risk management into daily practices
             ( Mr I. Sykes, PhD and director of Pharmaceutical Consultancy Services, Haarlem Netherl.)

15:30-15:45 Coffee break and networking
15:45-16:25 Case study: design and deployment of a multivariate risk
            management approach.
             (Mr M. Lupo, manager advanced methods at Johnson & Johnson, Italy )

16:25-17:00 Case study: risk management and cost reduction for recurring
            annual qualifications
             ( F. Heymans, process software validation teamleader at Alcon, Puurs)

17:00        Q & A and closing of the day with networking reception
                                                                                                     2
 MANAGE YOUR COST-IMPLEMENT RISK MANAGEMENT

A quality point of view on risk management ( D. T’ Jampens )

         Risk management within current regulations
         Best practices of using risk assessments
         ICH Q9 recommendations
         How can the use of risk management reduce the cost of quality?

Risk management: the complete picture ( R. Clonen )

         The risk management process
         Differences between the existing risk management tools
         Risks @ your department ( HR-Procurement-Projects-IT-Operations-Facilities
         Disaster recovery and crisis communication
         Do’s and Don’ts in risk management.

Case study: transition from commissioning and qualification to specification,
design and verification. ( M. Deconinck )

         Implementation of risk assessment based on products and process requirements as
          input to define risk control mechanisms
         Pro’s and contra’s of using risk managements versus traditional impact assessment
         Elimination of traditional DQ-IQ-OQ procedures
         Proof of fitness for use of installations through risk assessment procedures

Reduction of commissioning and qualification cost through risk based verification
( J. Slock )

         What is verification and how to use risk management approach?
         How to manage production risks related to product quality and patient safety?
         Cost measuring methods and results
         C & Q retrospective case study

Project cost risk assessment: “ How does J & J handles project contingency
( M. Lynch)

         What is cost risk assessment?
         Why and How J & J adopted this method?
         Differences between previous and present approach
         Description of cost risk assessment process and procedures and related key benefits
         Examples and case studies at J & J of cost risk assessment
                                                                                          3
Case study: Efficient risk management for a HVAC installation ( V. Meyer-L. Sinave)

           Risk analysis method on HVAC installation at Baxter Lessines
           Validation report of critical points in HVAC installation: pressure differentials-air
            velocity-air changes
           Cost reduction of validation and maintenance through risk assessment methods

Case study: cross contamination in a multiple purpose facility
Integrating risk management into daily practices ( I. Sykes )

           Case study of risk assessment in order to avoid cross contamination when producing
            two vaccines in the one building
           Different risk assessment methods to be used
           Practical aspects of risk management to operations

Case study: design and deployment of a multivariate risk management approach.
( M. Lupo )

           CPPM method ( Causal Process and Product Mapping ) integrates science based
            mapping with capabilities of modeling and simulation
           Multivariate risk management
           Risk based quality by design
           Lessons learned from the implementation at Janssen Cilag




Who should attend:

             Directors, managers and supervisors working in the engineering department or
              process development unit.
             Managers, engineers and supervisors who are responsible for pharma and/or
              biopharmaceutical manufacturing.
             Maintenance management and supervision.
             QA/QC/QP management and supervision responsible for validation, registration
              and batch release .
             Qualification and validation people responsible for engineering quality and
              technology development.




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                           REGISTRATION FORM SEMINAR May 26, 2009
                                       Please return before May 17
                    By fax at nr + 32 3 899 44 41 or e-mail : ISPEbelgium@aim.com
PARTICIPANT :
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PARTICIPATION IN THE COST (INCLUDING LUNCH AND PRESENTATIONS ON USB STICK ) :
Member of ISPE                                 : 260 €
Non-Member of ISPE                             : 450 € (including 1 year ISPE membership valued 190 €)

 I am ISPE member nr                                            and I pay 260 € for the participation through:
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 I am not yet an ISPE member and I pay 450 € for membership and participation through:
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Date :       .................................................   Signature : .....................................................
   ISPE reserves the right to delay the meeting and modify the program and the place, in case of force majeure.
   Confirmation of subscription will be sent one week before the seminar date together with a road map
   Any cancellation received later then one week before the event, will not be credited.


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