Double Your Education Opportunities in Process Validation
ISPE
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
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
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:
ISPE delivers technical and operational solutions to support across the global pharmaceutical and biopharmaceutical industry in the manufacture of quality medicines for patients.
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently announced the adoption of the revised guideline
The outlook for the biopharmaceutical market is promising, with expectations that the market will double in the next 10 years, resulting in new therapies and advances in biopharmaceutical manufacturing. This doesn't sound like much at first, but if you consider how the market has developed over the last 20 years, a doubling in the next 10 years is very significant.
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.