Auditing MDSAP and QSR Requirements – a 4-part webinar series

Rob Packard is hosting the Auditing MDSAP and QSR requirements four-part webinar series from August 9th to 30th, 2023.

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Register for the 4-part Webinar Series on Auditing MDSAP and QSR requirements for $299

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This is a 4-part webinar series that will be conducted live on August 9, 17, 23, and 30 (2023) via Zoom. The second webinar was rescheduled from 16th to 17th due to a scheduling conflict. This course assumes that the participant already has experience auditing to ISO 13485 and/or ISO 9001.
Price: $299.00

Outline for the Auditing MDSAP and QSR requirements webinar series

Registrants will receive a confirmation email because we deliver content and notification of updates through AWeber as an email subscription. After confirmation, you will receive login information for the four live Zoom webinars. Each of the four webinars will be approximately 45 minutes in duration, and the training content is organized as follows:

Session 1 – Auditing MDSAP and QSR requirements Kick-off – recorded on August 9, 2023

  1. What are the MDSAP and QSR regulatory requirements that you need to audit?
  2. Where do you find the MDSAP and QSR regulatory requirements?
  3. How are regulatory requirements different from quality system requirements (i.e., ISO 13485:2016)?
  4. How do you modify an audit schedule and your agenda to include regulatory requirements?
  5. Which documents do you need for audit preparation?
  6. How do you document your credentials (i.e., training competence) for regulatory requirements?

Session 2 – Auditing Management Processes & CAPA Process – recorded on August 17, 2023

  1. MDSAP Chapter 1 – Management
  2. MDSAP Chapter 3 – Measurement, Analysis & Improvement
  3. FDA QSIT – Management (except Purchasing & Supplier Controls)

Session 3 – Wednesday, August 23, 2023, @ 11:00 am EDT (live)

  1. MDSAP Chapter 2 – Device Market Authorization & Facility Registration
  2. MDSAP Chapter 4 – Adverse Event Reporting & Advisory Notices
  3. MDSAP Chapter 5 – Design Controls
  4. FDA QSIT – Design Controls

Session 4 – Auditing QSR & MDSAP requirements Finale – Wednesday, August 30, 2023, @ 11:00 am EDT (live)

  1. MDSAP Chapter 6 – Production & Service Controls
  2. MDSAP Chapter 7 – Purchasing
  3. FDA QSIT – Production & Process Controls
  4. FDA QSIT – Purchasing & Supplier Controls (sub-section of Management)

About Your Medical Device Academy Webinar Instructor Rob Packard

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Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the 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 certifications. 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’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 at 802.281.4381 or by email. You can also follow him on YouTubeLinkedIn or Twitter.

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