Share
May
6
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
May 6 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

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. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share
Jun
3
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Jun 3 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

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. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share
Jun
10
Mon
PMA Drafting Seminars
Jun 10 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a 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.

II.   About the Seminar 

  • PMA drafting track runs for eight 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
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
Share
Jul
1
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Jul 1 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

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. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share
Aug
5
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Aug 5 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

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. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share
Aug
12
Mon
PMA Drafting Seminars
Aug 12 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a 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.

II.   About the Seminar 

  • PMA drafting track runs for eight 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
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
Share
Sep
2
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Sep 2 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

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. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share
Oct
7
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Oct 7 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

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. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share
Oct
14
Mon
PMA Drafting Seminars
Oct 14 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a 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.

II.   About the Seminar 

  • PMA drafting track runs for eight 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
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
Share
Nov
4
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Nov 4 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

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. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

Share