Conference Day Two: 9th December 2009

08.30 Registration And Coffee

09.00 Chair’s Welcome

Dr Fadel Hamed
Associate Director, Head Of Operational Excellence
Genentech

Operational Excellence within the Supply Chain

09.15 Gaining Acceptance Of Lean In A Pharmaceutical Environment

  • Embracing common sense solutions
  • Utilisation driving continuous improvement
  • Cultural acceptance of production efficiency initiatives

Chris Gray
Head of Supply Chain Planning
Napp Pharmaceuticals

10.00 Project Selection For Lean-Six Sigma Deployment

  • Process excellence overview within Johnson and Johnson
  • Lean and six sigma road-maps
  • Project selection using dashboard metrics

Chet Damania
Master Black Belt
Johnson and Johnson

10.45 Networking Coffee Break

11.15 Case Study: Using Process Understanding To Mitigate Business Risk When:

  • Relocating to different manufacturing sites (Asia)
  • Transferring from R&D to Manufacturing
  • Moving from one API source to another

Tom Cochrane
Business Process Development Manager
Napp Pharmaceuticals

12.00 A Practitioners View: Using Lean 6 Sigma To Create A Climate For Improvement And Innovation

For further updates on Michael’s talk, please visit. www.opexpharma.com/MM

Michael Lee
Master Black Belt
AstraZeneca

12.45 Networking Lunch

14.00 Employment Of Lean Thinking In The Provision Of Pharmaceutical Manufacturing Capability

  • Employing risk management to maximise effectiveness and eliminate waste
  • The importance of process understanding in underpinning operational excellence

Mark O’Reilly
Senior Director of Engineering
Elan Pharmaceuticals

Sean Feeny
Associate Director, Operational Excellence
Elan Pharmaceuticals

14.45 Delivering And Sustaining Lean On The Shop Floor

  • Change on the shop floor
  • How to make change on the shop floor happen
  • Management infrastructure to sustain the change

Dermot O'Rourke
Operational Excellence Manager, Drug Substance
Wyeth Biotech

15.30 Networking Coffee Break

Regulation

16.00 Roundtables: Auditing For GMP Regulations: Ensuring Compliance

  • Planning your audit procedure: implementing review s of previous audits before building your onsite plan
  • Building corrective actions from your previous audits into your plan
  • What is the goal of your audit? Keeping the customer (end goal) in mind

Roundtables will be led by speakers from the conference

16.45 Chair’s Closing Remarks and end of day two

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