Track: QUALITY ASSURANCE & QMS

A4: Process Validation Lifecycle: 10 Years in Review

Moderator(s)

• 

  CDR Tara Gooen Bizjak, MBS

  Director, Manufacturing Quality Guidance and Policy Staff, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Panelist(s)

• 

  Conor Collins, PhD, MBA, MSc

  Head of Validation/PLM for Pharma Supply Technical
  GlaxoSmithKline
  Cork, Cork, Ireland

Regulatory Panelist(s)

• 

  Milind Ganjawala, MS, MBA

  Division Director, CDER
  U.S. FDA
  Silver Spring, Maryland, United States
• 

  Jeffrey Meng, MSE

  Director, Investigations Branch, OPQO, ORA
  U.S. FDA
  Royal Oak, Michigan, United States

Regulatory Presenter(s)

• 

  Milind Ganjawala, MS, MBA

  Division Director, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

  Presentation Handout

Presentations:

• 11:45 – 12:09 EDT

  Process Validation Lifecycle: Benefits and Learnings from Implementation
  

  Presenter: Conor C. Collins, PhD, MBA, MSc – GlaxoSmithKline
• 12:09 – 12:35 EDT

  Process Validation Lifecycle: 10 Years in Review
  

  Regulatory Presenter: Milind Ganjawala, MS, MBA – U.S. FDA
• 12:35 – 13:15 EDT

  Live Q&A (A4)
  

  Moderator: CDR Tara Gooen Bizjak, MBS – U.S. FDA

  Panelist: Conor C. Collins, PhD, MBA, MSc – GlaxoSmithKline

  Regulatory Panelist: Milind Ganjawala, MS, MBA – U.S. FDA

  Regulatory Panelist: Jeffrey D. Meng, MSE – U.S. FDA