Double Your Education Opportunities in Process Validation

Advancing the Validation Lifecycle Approach

Register now for the ISPE/PQRI Process Validation Conference on 24 – 26 October. For the past three years, this conference has offered a much needed professional development opportunity for individuals who write, review, or approve process validation plans including acceptance criteria, sampling plans, numbers of batches, and continued process verification. Key topics for this year's conference will be:

• PV lifecycle for a continuous manufacturing process
• Statistically based sampling for PV
• Excipient variability
• Demonstrating effective advanced process controls using continuous process verification Translating DOE data into filed process ranges
• Current Status of Asia/Pacific region process validation

Rick Friedman

Deputy Director, Office of Manufacturing Quality

CDER/FDA

Breaking New Ground with Statistics in the Process Validation Lifecycle

Register now for the ISPE/PQRI Process Validation Statistics Conference on 25 – 27 October. This ISPE/PQRI signature event has become a converging point for experienced and recent statisticians to to share best practices and exchange ideas in the evolving field of PV Statistics. This year's conference will expand your knowledge in:

• Reviewing statistics as an enabler of regulatory compliance of process validation
• Implementation of statistically-based routine release resting
• Using defect rate to determine PPQ & 3A sampling
• Statistical considerations in PV for continuous manufacturing
• Statistical considerations in PV for packaging
• Improved acceptance limits for ASTM Standard E2810 using a Bayesian approach

Tara R. Gooen Bizjak, CDR

Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality

OPQ/CDER, FDA

  Visit  the ISPE/PQRI 2016 Process Validation Statistics Conference website for additional conference details.

Special Joint Sessions

Attendees at both conferences will come together for two combined special sessions:

• PV statistics primer the evening of 25 October featuring Statistical Tools for PV for Non-Statisticians and Controversial Statistical Considerations for Statisticians
• Half-day Combined Regulatory Session for PV and PV Statistics attendees on 26 October featuring:

Lawrence X. Yu, PhD Director, Office of New Drug Products OPQ/CDER/FDA

Ashley Boam Director, Office of Policy for Pharmaceutical Quality, OPQ FDA/CDER/OPQ/OPPQ