A Lead Auditor is responsible for leading an audit team in an organization—preparing the audit plan, delivering meetings and submitting audit reports. AAMI’s 2-day Lead Auditor course teaches participants the requirements of and how to utilize ANSI/AAMI/ISO 13485. Join us to gain understanding of best practices of auditing quality managements systems as defined in ANSI/ISO 19011.
Join us to benefit from…
- Learning about the requirements for internal auditing in today's international medical device market
- Sharing best audit practices with experienced AAMI faculty and your fellow attendees
- Completing hands-on exercise for conducting remote QMS audits, as many companies now require during COVID pandemic
- Understanding the latest updates on MDR status and how to work with your Notified Body
Registration includes copies of current ISO 13485 standard and 19011 auditing standards, an AAMI course completion and a QMS auditing exam qualification record, and enrollment in AAMI post-course community group.
Please note: This course is being held virtually.
|AAMI Members||Nonmembers||Government Employees|
From July 23 to August 1, registrations for this course must be completed via form submission while we upgrade our registration system. Please direct any questions to firstname.lastname@example.org. Thank you for your patience while we work to improve your online experience.
Meet your faculty: Rob Packard and Jack Ward
- Rob Packard
- President, Medical Device Academy
Rob Packard is a regulatory consultant with 30 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.
Rob is the founder and President of Medical Device Academy. The company was incorporated in October of 2013, but he wasn’t smart enough to get some full-time help until 2016. Rob is constantly doing everything to extremes. That includes Zoom meetings with Austria, Sweden, Netherlands and Israel at 6am; and Skype calls with China and Australia and 10pm. He of course “balances” this out with two and three workouts a day, and a good novel until midnight. The picture above shows Rob at the end of a training hike with his dad (77 years old). I wonder where he gets his extreme personality from?
- Jack Ward
- President, Ward Sciences and Consulting, LLC
Jack Ward is a recognized quality assurance and regulatory affairs professional with over 35years experience in the medical device industry. Jack has held a broad range of corporate management, engineering and Quality/Regulatory positions with direct experience across a broad range of medical device types, technologies and applications.Jack’s company, Ward Sciences and Consulting LLC, provides consulting expertise to medical device companies for Quality Systems implementations and training. His company can provide specific expertise for IVD, NGS and companion diagnostics, software and other complex medical device types with focus on FDA, ISO and MDSAP requirements.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email email@example.com.