This 50+ minute webinar provides information related to:
- Defining an unannounced audit-frequency
- Audit focus-how many auditors will conduct the inspection? How many different device types can you expect to be sampled? Opening meeting-what questions typically will auditors be asking you?
- Which processes will auditors sample? (i.e., sterilization)
- Incoming inspection-areas of focus
- Supplier controls
- Final inspection
- Design controls
- Why the Device Master Record (DMR) is a key focus area
- Defining “critical subcontractors” and “crucial suppliers”
- Question and Answer session
This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
Includes native PowerPoint Files
Exam and Training Certificate available for $49.00:
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 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.