FDAnews Announces — Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny Webinar, June 27, 2017

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A QA/QC expert has come up with a “roadmap” to steer drugmakers through the FDA’s complex of steps and guidelines surrounding process validation.

Develop a Process Validation Roadmap:
Case Studies Show How to Satisfy FDA’s Scrutiny
**An FDAnews Webinar**
June 27, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/processvalidroadmap

If drugmakers aren’t revalidating their processes and using their change control SOPs, they’re headed for 483s and recalls that could cost millions of dollars.

Most drug and biologics manufacturers struggle to comply with the FDA’s process validation (PV) guidance. Many don’t even want to apply the guidance to avoid having to revalidate their processes.

Oh, for a “roadmap” to guide manufacturers.

Meet Kelly Thomas. She has developed just such a “roadmap.” Now she’s ready to share it.

Mark the calendar for Tuesday, June 27, when Ms. Thomas reveals her findings during an FDAnews-sponsored webinar. She will cover the following:

  •     Exactly what the FDA expects a process control strategy to include
  •     What the design of the facilities should look like
  •     The qualifications of utilities and equipment at a facility
  •     The process performance qualification
  •     What factors process validation looks at
  •     The regulatory trends that revolve around PV
  •     Case studies with valuable PV lessons

Ms. Thomas, VP-Quality at Atlantic Technical & Validation Services, is an expert at developing, implementing and managing QA/QC activities affecting cGMP operations in drug, biologics and device firms.    

Process validation shouldn’t be all that difficult. Here’s how to make it really easy.

Meet the Presenter:

Kelly Thomas is Vice President of Quality at Atlantic Technical & Validation Services. She boasts 18 years’ experience developing, implementing and managing QA/QC activities affecting cGMP operations in drug, biologics and device firms, including developing and implementing Quality Systems consistent with strategic missions, customer expectations and regulatory requirements. Ms. Thomas holds an MBA from Meredith College and maintains several professional certifications from the American Society for Quality (ASQ).

Who Will Benefit:

  •     QA/QC Personnel
  •     Process Owners
  •     Quality Managers
  •     Quality Engineers
  •     Manufacturing Managers
  •     Manufacturing Supervisors
  •     Manufacturing Engineers
  •     Process Engineers
  •     Development Engineers
  •     Project Managers
  •     Operations Managers
  •     Validation Managers
  •     R&D Personnel

Webinar Details:
Develop a Process Validation Roadmap:
Case Studies Show How to Satisfy FDA’s Scrutiny
**An FDAnews Webinar**
June 27, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/processvalidroadmap

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/processvalidroadmap                                                                                        
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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Michelle Butler
FDANEWS
+1 (703) 538-7665
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