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Pharmaceutical Process Validation Webinar on August 3, 2022

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FALLS CHURCH, Va. (PRWEB)

Pharmaceutical Process Validation

Best Practices for Success

An FDAnews Webinar

Wednesday, Aug. 3, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/pharmaceutical-process-validation

The FDA is taking a tougher stance on deficiencies relating to current good manufacturing practices (cGMP). Drugmakers can avoid the inevitable warning letters and potential production stoppages and recalls when they shore up their process validation with the best practices in this webinar.

It will enable drugmakers to understand the importance of process validation throughout a product’s lifecycle, from concept, development, scale-up and production, through decommissioning.

Best of all, it will empower them to identify, control and ultimately reduce variability at every step. All while increasing homogeneity within and between lots and preventing FDA enforcement action.

John E. Lincoln, principal of J.E. Lincoln and Associates, will explain the takeaways from 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 attendees to integrate process validation essentials into their quality management system (QMS).

He’ll share how to develop, validate and refine processes to ensure their reliability, consistency and efficacy when attendees:


  • Understand the key points in the FDA’s process validation guidance document

  • Appreciate the value of their company when they 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 they can quickly and effectively communicate with both internal and external stakeholders

  • Get the gold-standard validation master plan and individual plans — with examples they can use with all their partners and stakeholders

  • Understand how to use verification and validation test report formats

The FDA is cracking down on process variation issues. If drugmakers want to ensure pharmaceutical process consistency, this webinar is essential.

Webinar Details

Pharmaceutical Process Validation

Best Practices for Success

An FDAnews Webinar

Wednesday, Aug. 3, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/pharmaceutical-process-validation

Tuition:

$287

Easy Ways to Order:

Online: https://wcg.swoogo.com/pharmaceutical-process-validation

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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