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2017 Process Validation Conference

The pharmaceutical industry has made significant progress in the area of process validation (PV) with recent regulatory guidance to a more scientifically sound lifecycle approach to PV with more proactive awareness of process variability and response. While much progress has been made in industry, there are still areas of challenge and additional opportunities. ISPE's Process Validation Conference, will help attendees to interpret via shared discussions and case studies, presented by peers, showing the progress made in all areas of the validation lifecycle and benefits realized from implementing this newer paradigm. Delegates will have the opportunity to benchmark with real examples of successes and challenges shared by other professionals and companies.
9/12/2017 - 9/13/2017
Bethesda Marriott
5151 Pooks Hill Rd
Bethesda, MD 20814 USA


Program

   

Tuesday, 12 September 2017

 
Welcome, Agenda for the Day, Introductions and Benchmarking|
Time:
8:30 AM - 9:00 AM
8:30 AM
Keynote: FDA Perspective on Process Validation for Biotech Products|
Time:
9:00 AM - 9:45 AM
9:00 AM
A Risk-Based Approach for Process Validation Stage 1- 3 Implementation|
Time:
9:45 AM - 10:25 AM
9:45 AM
Networking Break|
Time:
10:25 AM - 10:55 AM
10:25 AM
Criticality Assessment in Process Validation Stage 1|
Time:
10:55 AM - 11:35 AM
10:55 AM
PPQ on a New Flexible Vial Aseptic Filling Line: Case Study|
Time:
11:35 AM - 12:15 AM
11:35 AM
Lunch|
Time:
12:15 PM - 1:15 PM
12:15 PM
Process Validation Benchmarking|
Time:
1:15 PM - 1:30 PM
1:15 PM
Translating Stage 1 Data to NOR, PAR and the Control Strategy: Small Group Exercise|
Time:
1:30 PM - 2:30 PM
1:30 PM
Estimation of the Number of Batches Required for Validation of Solution Container Material and Manufacturing Process Modifications|
Time:
2:30 PM - 3:10 PM
2:30 PM
Networking Break|
Time:
3:10 PM - 3:40 PM
3:10 PM
Sampling and Acceptance Criteria for Process Performance Qualification - ISPE Discussion Paper (Draft)|
Time:
3:40 PM - 4:05 PM
3:40 PM
Development of Attribute Process Validation Sampling Plans|
Time:
4:05 PM - 4:35 PM
4:05 PM
Q&A and Process Validation Benchmarking|
Time:
4:35 PM - 5:15 PM
4:35 PM

Wednesday, 13 September 2017

 
Agenda for the Day and Process Validation Benchmarking Session|
Time:
8:00 AM - 8:30 AM
8:00 AM
Keynote: Stage 3 Process Validation and the Role of Quality Risk Management|
Time:
8:30 AM - 9:15 AM
8:30 AM
OPV Process and Decision Making for Large Molecule Drug Substance: Case Study|
Time:
9:15 AM - 9:50 AM
9:15 AM
Apply Lean Thinking to Optimize CPV|
Time:
9:50 AM - 10:30 AM
9:50 AM
Networking Break|
Time:
10:30 AM - 11:00 AM
10:30 AM
Process Validation Benchmarking|
Time:
11:00 AM - 11:30 AM
11:00 AM
Equipment Robustness Program and Case Study|
Time:
11:30 AM - 12:10 PM
11:30 AM
Lunch|
Time:
12:10 PM - 1:10 PM
12:10 PM
Stage 3a Heightened Monitoring and Testing Decisions - Application to a Post PPQ Scenario: Small Group Exercise|
Time:
1:10 PM - 2:10 PM
1:10 PM
Process Validation for Accelerated/Breakthrough Programs|
Time:
2:10 PM - 2:50 PM
2:10 PM
Process Validation in the Context of Continuous Manufacturing Processes|
Time:
2:50 PM - 3:30 PM
2:50 PM
Networking Break|
Time:
9/13/2017 3:30 PM - 9/13/2000 4:00 PM
3:30 PM
Process Validation for Packaging for Oral Solid Dosage Products: ISPE Draft Discussion Paper|
Time:
4:00 PM - 4:25 PM
4:00 PM
Packaging Validation for an Oral Solid Dosage Bottle Filling Process: A Case Study|
Time:
4:25 PM - 4:55 PM
4:25 PM
Closing Remarks and Next Steps|
Time:
5:10 PM - 5:30 PM
5:10 PM
Combined Reception|
Time:
5:30 PM - 6:30 PM
5:30 PM
Statistical Tools for Process Validation: A Refresher|
Time:
9/13/2017 6:30 PM - 6/13/2017 8:00 PM
6:30 PM
Open Forum on Draft EMA Reflection Paper on Statistical Methodology|
Time:
6:30 PM - 8:00 PM
6:30 PM

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 Lifecycles Implementation Progress in Europe and Asia|
Time:
10:35 AM - 11:05 AM
10:35 AM
FDA View of the Maturity of Process Validation Lifecycle Implementation|
Time:
11:05 AM - 11:40 AM
11:05 AM
Lunch|
Time:
12:00 PM - 1:00 PM
12:00 PM
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Pre-registered attendees will need to present their registration confirmation or ID at the registration desk. If you did not receive a confirmation letter, please contact ISPE Member Services Department at ask@ispe.org or Tel: +1-813-960-2105