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2017 Process Validation Statistics Conference

The 2017 Process Validation Statistics Conference continues to build on the success of the previous conferences. The forum provides an exceptional opportunity for statisticians and those skilled in the use of statistics to discuss and debate state-of-the-art approaches to implementing statistical elements that support the Lifecycle Approach to Process Validation. With expectations for statistically-based sampling plans and use of statistical evaluation in all stages of process validation increasing both in the US and the rest of the world, this program will provide you with insights and practical approaches to meet these expectations. FDA and industry leaders will share current thinking and realistic options to improve your company’s approach to Process Validation. The program is designed for experienced statisticians and process validation professionals with a considerable working knowledge of statistics.
9/13/2017 - 9/15/2017
Bethesda Marriott
5151 Pooks Hill Rd.
Bethesda, MD 20814 USA


Program

   

Thursday, 14 September 2017

 
Welcome and Opening Remarks, Pigeonhole Orientation|
Time:
8:30 AM - 8:40 AM
8:30 AM
ISPE's Involvement in ICH Q12 - Spreading Understanding|
Time:
8:40 AM - 9:15 AM
8:40 AM
Clinically Relevant Specifications|
Time:
9:15 AM - 9:50 AM
9:15 AM
Networking Break|
Time:
9:50 AM - 10:10 AM
9:50 AM
Industry Maturity in the Assessment and Use of Process Capability|
Time:
10:10 AM - 10:35 AM
10:10 AM
Process Validation Lifecycle Implementation Progress in Europe and Asia|
Time:
10:35 AM - 11:05 AM
10:35 AM
Panel Discussion|
Time:
11:40 AM - 12:00 PM
11:40 AM
Lunch|
Time:
12:00 PM - 1:00 PM
12:00 PM
Welcome, Introductions, Agenda for the Day and Benchmarking Session|
Time:
1:00 PM - 1:30 PM
1:00 PM
Keynote: The EMA (Draft) Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes|
Time:
1:30 PM - 2:15 PM
1:30 PM
Analytical QbD - Analytical Variability to Process Variability|
Time:
2:20 PM - 3:05 PM
2:20 PM
Networking Break|
Time:
3:05 PM - 3:30 PM
3:05 PM
Implementation of Transmission Raman Spectroscopy for At-line Unit Dosage Uniformity Prediction|
Time:
3:30 PM - 4:00 PM
3:30 PM
Interactive Group Breakouts|
Time:
4:00 PM - 5:00 PM
4:00 PM

Friday, 15 September 2017

 
Welcome, Agenda for Day 2 and Benchmarking|
Time:
8:30 AM - 8:45 AM
8:30 AM
Considerations for Continuous Manufacturing Implementation Throughout a Product Lifecycle: FDA Perspective|
Time:
8:45 AM - 9:30 AM
8:45 AM
Report Out from the Interactive Breakout Groups|
Time:
9:35 AM - 10:30 AM
9:35 AM
Networking Break|
Time:
10:30 AM - 10:55 AM
10:30 AM
A PV-1 Statistical Approach to Aid Process Parameter Criticality Assignment|
Time:
11:00 AM - 11:30 AM
11:00 AM
ISPE PV Good Practice Guide including New Statistically Based Criteria for Content Uniformity

ISPE Papers: PV for Packaging and PV for Breakthrough Products|
Time:
11:30 AM - 12:30 PM
11:30 AM
Lunch|
Time:
12:30 PM - 1:30 PM
12:30 PM
Evolving CPV Trends: Leveraging the Control Strategy|
Time:
1:30 PM - 2:00 PM
1:30 PM
Opportunities and Challenges for Statisticians in Risk Assessment Throughout the Product Lifecycle|
Time:
2:00 PM - 2:30 PM
2:00 PM
A Standardized Approach to Bayesian PPQ Sample Size Implementation Using R-shiny|
Time:
2:30 PM - 3:00 PM
2:30 PM
Networking Break|
Time:
3:00 PM - 3:20 PM
3:00 PM
Statistician's Perspective on Contract Manufacturing|
Time:
3:30 PM - 4:00 PM
3:30 PM
Benchmarking Trends Over the Years for PV Stats
Discussion of Benchmarking Results
Input on Next Steps for the ISPE PV Team|
Time:
4:00 PM - 4:30 PM
4:00 PM
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