Some of the largest and most expensive recalls ever were caused by inadequate process validation. The reason is because the defective product that process validation is supposed to prevent cannot be verified by inspection. That’s why process validation is required, and that’s why reviewing validation is the most critical element of production and process controls—one of the four major quality systems the FDA focuses on for inspection.
In this presentation, Rob Packard discusses the most important aspects of developing a Master Validation Plan, validation protocols and validation reports. You will learn how to audit your own process validations to identify weaknesses, and you will learn how to use validations as part of your Corrective And Preventive Action (CAPA) process.
This webinar covers:
- What needs to be in a Master Validation Plan
- What are the most common FDA 483s related to validation
- Critical aspects of designing an IQ, OQ and PQ
- Guidance documents for process validation
- Auditing process validation
This webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):
Includes Native PowerPoint Presentation
Exam and Training Certificate available for $49.00:
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About Your Instructor
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others.
Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email.
You can also follow him on Google+, LinkedIn or Twitter.