This 510(k) or PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket notification [510(k)] submission or premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.
This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.
About the Seminar
- 510(k) drafting track runs for five weeks as a small group (2-5 people or a group).
- Each class is scheduled during the weekdays. Curriculum may be subject to slight change on a needed basis.
- One class per week
- For 510(k) drafting: seminar begins bi-monthly or by scheduling
- Flexible scheduling – it can be adjusted on a needed basis.
- 510(k) drafting: second Mondays at 11 AM or 03 PM EST (60 minutes) – January, March, May, July, September and November
- PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
About the 510(k) Drafting Track
510(k) drafting track is comprised of five (5) LIVE webinars.
- 510(k) format and contents
- Guidances and standards
- Pre-submission/Q-subs; FDA-cleared 510(k)s
- FDA-cleared 510(k)s
- Technical issues and practical tips
Each 510(k) LIVE webinar runs for 60 minutes.
- 510(k) drafting track is $1,499.
- It is payable upon signing.
About the Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products. In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance. Recently, Dr. Lim developed 510(k) templates ready for immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.
Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
Option 2: you may request an invoice by email to Global Compliance Seminar
Option 3: you may purchase online below using a credit card or PayPal.
LIVE (one attendee): $1,499
LIVE (≤ 3 attendees): $3,999
LIVE (≥ 4 attendees): $5,999
LIVE & Recorded: $2,499