Rob Packard, QA/RA Expert, Medical Device Academy, provides a comprehensive review of a range of topics, including definitions of basic terminology to his top 5 risk management mistakes; what he looks for when auditing and much more. He utilizes diagrams and charts for explanation to illustrate key points in the document. (See Risk Management is a Process below).
In addition, he discusses how to address the seven deviations identified in EN ISO 14971:2012.
Implementing a Risk Management Process Compliant with ISO 14971
Example of Top 5 Risk Management Mistakes
1. Not reading the Annexes
2. Using Annex C, Questions 1-34 as your only form of Hazard Identification
3. Using only some of the tools in Annex G
4. Too much energy spent during design upon identifying P1 vs. P2 (see Figure E1, Annex E)
5. Not updating risk management documentation
This Recording and Native PowerPoint Presentation is only 129.00
Implementing a Risk Management Process Compliant with ISO 14971:2007 webinar recording is a must have resource guide on the critical aspects of this topic.
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.
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About Your Instructor
Robert Packard is a regulatory consultant with ~25 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. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.