Process Validation Conference, 12 -14 September 2017, Bethesda Marriot, Bethesda, MD

Education Program

Explore Current Trends in Practical Application of the Lifecycle Approach to Process Validation

Keeping up with its tradition, the 2017 ISPE Process Validation Conference will:

  • Identify practical solutions for regulatory expectations
  • Benchmark approaches to solve real-life problems
  • Demonstrate solutions to ensure an ongoing state of control, by showcasing Process Validation Lifecycle Approach success stories
  • Address expectations for the application of statistics in lifecycle Process Validation - what tools can be used and how to respond
  • Set the stage for moving from a solely compliance driven mindset to a culture of quality and continuous improvement

Topics include:

  • New Process Validation Guidance in relation to CMO, client responsibility, and accountability
  • Continuous processing and qualification
  • Small molecule Active Pharmaceutical Ingredient (API) validation and how it links to drug product
  • Continuous manufacturing examples for other platforms
  • Emphasis on Stage 1, 2, and 3 of the process validation lifecycle
  • Industry standard confidence level and reliability level, during process validation based risk assessment

Schedule at a Glance

Tuesday, 12 September 2017

08.30–10.00 General/Keynote Session
10.00–10.30 Networking Break
10.30–12.30 Education Sessions
12.30–13.30 Lunch
13.30–15.00 Education Sessions
15.00–15.30 Networking Break
15.30–16.30 Interactive Exercise
16.30–17.15 Panel Discussion

Wednesday, 13 September 2017

08.30–10.00 General/Keynote Session
10.00–10.30 Networking Break
10.30–12.30 Education Sessions
12.30–13.30 Lunch
13.30–15.00 Education Sessions
15.00–15.30 Networking Break
15.30–16.30 Interactive Exercise
16.30–17.15 Panel Discussion

Thursday, 14 September 2017

08.30–10.00 Combined Sessions with Process Validation Statistics Conference Attendees
10.00–10.30 Networking Break
10.30–12.00 Combined Sessions with Process Validation Statistics Conference Attendees
13.00 Conference Adjourns

 

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Presentations & Attendee Roster

Conference Attendees: