Pharmaceutical Process Validation: Best Practices for Success – Webinar Recording/Transcript
Process validation success starts here.
While it’s true that the FDA is taking a tougher stance on deficiencies relating to current good manufacturing practices (cGMP), you can avoid the inevitable warning letters and potential production stoppages and recalls. Shore up your process validation with the best practices in this webinar.
It will enable you to understand the importance of process validation throughout your product’s lifecycle, from concept, development, scale-up and production through decommissioning.
Best of all, it will empower you to identify, control and ultimately reduce variability at every step. All while increasing homogeneity within and between lots.
John E. Lincoln, principal of J.E. Lincoln and Associates, will share how to uncover any lack of sufficient or targeted risk-based process verification and validation planning/execution – a major flaw for many.
By examining the FDA’s process validation guidance document and the must-have elements from ISO 14971:2019 (Application of Risk Management to Medical Devices) as a model for a pharmaceutical version and ICH Q9 – Quality Risk Management for hazard analysis, patient/product/process risk management and risk-based decisions, Mr. Lincoln will help you to integrate process validation essentials into your quality management system (QMS).
When you know the process to reduce variation, grow in-process knowledge and improve product-critical quality attributes that lead to improved overall quality, you’ll ensure reliability, consistency and efficacy. And success.
- Understand the key points in the FDA’s process validation guidance document
- Appreciate the value to your company when you put these principles into practice
- Recognize the key process, equipment (production/test/lab), hardware and software, and QMS/21 CFR 11 verification and validation activities
- Discover and use the lessons learned from sample test cases for installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Part 11 and cybersecurity requirements
- Become familiar with the working definitions for verification, qualification, validation, commissioning/decommissioning and related terms so you can quickly and effectively communicate with both internal and external stakeholders
- Get the gold-standard validation master plan and individual plans — with examples you can use with all your partners and stakeholders
- Understand how to use verification and validation test report formats
The FDA is cracking down on process variation issues. If you want to ensure pharmaceutical process consistency, this webinar is essential.
Meet Your Presenter
John E. Lincoln is principal of J.E. Lincoln and Associates, a consulting company with more than 40 years of experience in FDA-regulated industries, including 26 years at an independent consulting company. He has worked with companies from startups to Fortune 100 in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. Mr. Lincoln specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971/ICH Q9, product risk management files/reviews, and design control/design history files and technical files.
Who Will Benefit
Various pharmaceutical company personnel, including:
- Senior management (CEO, COO, etc.)
- Manufacturing engineering
- Quality assurance/QAE professionals
- Regulatory affairs professionals
- Production management and staff
- Software engineering staff
- Facilities engineering staff
Webinar Recording & Transcript Bundle
Add to Cart
Aug. 3, 2022