Medical Device Academy is planning to relaunch our lead auditor training course as an on-demand webinar series in Q1 2025
Why is Lead-Auditor Training Online?
Medical Device Academy’s lead auditor training course was previously offered as an on-site, live training course for private companies. Post-pandemic, everyone wants to learn from home. We also see many more companies choosing to conduct quality system audits remotely. Since Medical Device Academy’s entire team already works 100% remotely, there is no other auditing team that is more experienced at conducting remote audits with Zoom. The instructors also developed three previous lead auditor courses. The estimated time to complete the online course is ~24 hours (i.e., three days)–not including the final exam (~2 hours).
When will the online Lead-Auditor training launch? and how much will it cost?
The three-day online lead auditor course will be available in Q1 2025, but we don’t have a launch date yet. The course will be released as six separate modules. Each module is estimated to be ~4 hours in duration (i.e., a half-day). Each module will be concluded with a quiz to verify training effectiveness. The modules will be priced at $300/each, and the final exam will cost $200. More details about the course and each module will be provided over the next three months. Once final, the course will cost $2,000/person.
Does Medical Device Academy also offer on-site training?
We also offer on-site lead auditor training. The on-site training is also three days in length. We conduct six short quizzes throughout the course to make sure participants understand the material covered before we move on to the next training segment. At the end of the course all participants are provided with a final take-home written exam. The cost of the on-site lead-auditor training is $3,500/day plus travel. If you want a quote for the on-site auditing course or an audit quote, please contact Lindsey Walker.
Lindsey Walker, Director of Sales
Lindsey Walker studied at Castleton University, way back when it was just a little old Castleton State College in Castleton, Vermont, where she received her BS in Business Marketing. She also studied at North Country Community College, where she received her Certificate in Practical Nursing. Besides preparing proposals and sending out invoices, Lindsey was recently promoted to Director of Sales. In this new position, she is responsible for managing the sales team, coordinating introductory calls with our clients, creating proposals, and managing our new billing clerk. Lindsey loves cars, but when she is not behind the wheel of one, you can find her on a pottery wheel.
Email | lindsey@medicaldeviceacademy.com Tel | (802) 989-3939
This on-line lead auditor training course includes:
- Audit Preparation & Planning (1st & 2nd party)
- How to Conduct Opening & Closing Meetings
- Interviewing Techniques
- Audit Note Taking (remote and on-site methods)
- Videos demonstrating best practices and mistakes
- Examples of records to audit
- Approaches to Quality System Auditing
- Auditor Selection & Ongoing Training
- Audit Team Management
- Audit Program Planning
- How to Eliminate the Need for Checklists
- Tutorial on writing nonconformities
- Tutorial and report writing
- Audit Follow-up
- Stories, anecdotes, and case studies
How do we evaluate training effectiveness for lead auditors:
Medical Device Academy has invested in a new training platform called LearnDash. There are five short quizzes and a final exam administered via LearnDash. The quizzes are automatically graded by LearnDash, while the final exam is graded automatically by LearnDash except for the section for writing non-conformities that is graded manually by one of the instructors. Quizzes and the final exam are “open book and notes.” The Lead Auditor Training Certificates are issued automatically via LearnDash.
Reference Materials Needed:
Students will also need access to a copy of the following documents:
- ISO 13485:2016 (you can purchase at https://evs.ee/)
- ISO 19011:2018 (you can purchase at https://evs.ee/)
The online lead auditor training course is self-paced, 100% virtual, and available on demand. The course requires prior knowledge of ISO 13485:2016, but Medical Device Academy has ISO 13485:2016 training webinar available on-demand as well.
Your Lead Auditor Course Instructors:
Rob Packard
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. From 2009 to 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 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.
Matthew Walker
Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Management Systems, Technical/Medical Writing, and is a Lead Auditor. Matthew has updated all of our procedures for He is currently a student in Champlain College’s Cyber Forensics and Digital Investigations program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College. He can be reached by email. You can also follow him on LinkedIn or YouTube.