Thursday July 25, 2019
12:00 pm – 1:30 pm EDT
Instructor: Nissan Cohen
Abstract:
Process Analytical Technology (PAT) was released to the pharmaceutical industry by the FDA in September 2004, almost 15 years ago. Why hasn’t the industry adopted en masse this excellent technology in lieu of traditional validation and operations? Why has the industry been reticent to adopt all of the “Guidelines for the 21st Century” as outlined by the FDA in 2004?
Find out how this technology has important implications for continuous manufacturing, continuous operations, 24/7 operations, production cost savings, validation savings, and regulatory scrutiny.
This presentation is informative and educational depicting the FDA’s incentives for adoption of this technology and program.
Who should attend?
- Production Management
- Engineering
- Validation
- QA/QC
- Subject Matter Experts in process production, and identification of CPPs and CQAs.
Areas Covered in the Webinar:
What is Process Analytical Technology?
Why was PAT part of the FDA’s 21st Century Guidances?
Implementation of PAT
Cost Savings of implementing PAT versus Traditional Validation
PAT’s role in Continuous Manufacturing
Regulatory Incentives by adoption of PAT
PAT enhances reduction of production waste, downtime, OOS incidents, and errors.
PAT ensures better process knowledge, throughput, and product quality
The advantages of online instrumentation versus laboratory instrumentation and manual sampling
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-124