LIVE Online PMA Seminars: How To Draft a PMA Like a Pro. FDA medical device premarket approval (PMA) drafting LIVE online seminars are specifically designed to help regulatory affairs and other professionals draft a PMA application in a highly efficient and effective manner. To contact the seminar speaker (Dr. David Lim), please email him at david@regulatorydoctor.com. To learn more about PMA seminars, please visit Global Compliance Seminar at http://globalcomplianceseminar.com

1. Copyright © 2013 Global Compliance Seminar. All Rights Reserved.
How to Draft a PMA Like a Pro
David Lim, Ph.D., RAC, ASQ-CQA
President and Principal
www.REGULATORYDOCTOR.com
Email: David@RegulatoryDoctor.com
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Global Compliance Seminar™
Date: Weekly 90 Minutes | 8 Weeks
LIVE | Online
Time: Flexible

2. Copyright © 2013 Global Compliance Seminar. All Rights Reserved.
Seminar Format
 LIVE Online
– 90 Minutes of LIVE Seminar Weekly
– Eight (8) Weeks
– Eight (8) Times
– 12 Hours of Seminars
 *Recorded Seminars (Available Now)
– 8 Recorded Seminars x 90 Minutes Each
– 12 Hours of Seminars
 Your Best Investment in Your Career!!!
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3. Copyright © 2013 Global Compliance Seminar. All Rights Reserved.
Scope
 The PMA drafting seminars are intended
to provide practical guidance and direction
on PMA Content, Format and
Submission.
 It is focused on “HOW.”
 It is intended to be applicable to all
medical device product types requiring
PMAs.
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4. Copyright © 2013 Global Compliance Seminar. All Rights Reserved.
Goals & Objectives
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PMA Regulatory
Requirements
PMA Submission
and Clearance
Laws and Regulations
Requirements
PMA Process
Relevant &Applicable
Information: Performance
Requirements
Compiling a PMA
Quality Submission, FDA Panel
Meetings, and Approval

5. Copyright © 2013 Global Compliance Seminar. All Rights Reserved.
Scheduled Subjects
(Weeks 1 Through 4)
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1 PMA Process: Overview
2 PMA Regulatory Requirements
3 Review: Guidance Docs & Stds
4 PMA Submission Quality

6. Copyright © 2013 Global Compliance Seminar. All Rights Reserved.
Scheduled Subjects
(Weeks 5 Through 8)
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5 Quality System Regulations
6 PMA Contents and Format
7 PMA Template Reviews
8 PMA Templates - Cases

7. Copyright © 2013 Global Compliance Seminar. All Rights Reserved.
Week One: PMA Overview
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Laws and Regulations1.
PMA Review Process?3.
Benefit-Risk Determinations5.
What is a PMA?2.
Filing a PMA – Refuse to File4.
PMA Submission Checklist,
Review and Approval
6.
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8. Copyright © 2013 Global Compliance Seminar. All Rights Reserved. 8
Questions?
 To learn more about our PMA seminars, please visit us
at http://www.globalcomplianceseminar.com
 Email us at info@globalcomplianceseminar.com
OR
 Call Us at (731)-Go-To-GCS (468-6427)