Complaint Handling and Medical Device Reporting are two of the FDA’s most frequently issued 483s and Warning Letters. ISO auditors and FDA inspectors alike review complaint records during every visit. In this webinar you will learn:

• Deadlines for Complaint Investigations and Reporting
• What to do when defective product is not returned
• Benefits of automated software solutions
• How to audit your complaint handling process
• Differences between US, European & Canadian requirements

Exam and Training Certificate available for $49.00:

EXAM – Complaint Handling and Vigilance Reporting

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

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This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):

Complaint Handling and Vigilance Reporting Webinar

Complaint Handling and Medical Device Reporting are two of the FDA’s most frequently issued 483s and Warning Letters.

Price: $129.00

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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.