FDA Medical Device Recalls, Labeling and 21 CFR 820.120

Many companies struggle with deciphering FDA medical device recall regulations and misinterpret 21 CFR 806 (http://bit.ly/21CFR806-Recall). Fortunately, FDA 483 inspection observations can be easily avoided by doing two things. First, personnel responsible for corrections and removals need proper training—not just “read and understand.” Second, your forms and procedures need to comply fully with 21 CFR 806.

This 70+ minute information-packed webinar recording reviews critical considerations in conducting an effective 8-step recall in compliance with 21 CFR 806. One of the most common recalls is related to labeling errors. The impact of labeling errors can be significant to a patient. How to prevent labeling mixups is reviewed. You will also learn the 7 steps to conducting an effective process audit of both labeling and a recall.  

FDA’s involvement in recalls-what actions do they take in performing an effectiveness check?  What are the 5 most common mistakes related to compliance with 21 CFR 806? What if you make a mistake-what are the regulatory consequences?  These questions and more are answered in this webinar. 

You also receive information links for recalls regulations, recalls database, guidance documents and FDA recall coordinators.  

 

FDA Recall 01 FDA Medical Device Recalls, Labeling and 21 CFR 820.120

 

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

FDA Recall 011 FDA Medical Device Recalls, Labeling and 21 CFR 820.120
FDA Medical Device Recalls, Labeling and 21 CFR 820.120
Price: $129.00

Exam and Training Certificate available for $49.00:

exam10 150x150 FDA Medical Device Recalls, Labeling and 21 CFR 820.120
EXAM – 7 Steps to Respond to a 483 Inspection Observation

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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SOPS FDA Medical Device Recalls, Labeling and 21 CFR 820.120

About Your Instructor

Medical Device Academy Robert Packard FDA Medical Device Recalls, Labeling and 21 CFR 820.120Robert 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.

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