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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
4
Tue
Understanding Pain Management and Opioids
Jun 4 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Understanding Pain Management and Opioids: FDA Regulations, Generics and Recent Approvals

  • Date: June 4, 2019
  • NOTE: This seminar recurrs tri-monthly (every three month) on 1st Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes

About the Seminar

Pain Management OpioidsThe United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities.

Opioids as prescription drugs are used to reduce chronic pain.  Opioids offer both great benefits and also serious risks, potentially causing serious harm (addiction, overdose and even death) when misused or abused.

This seminar is intended to help industry and professionals to better understand FDA roles and regulation governing controlled substances (opioids) used for pain management. This seminar is also intended to help industry get better familiar with FDA’s recent activity and regulatory expectations  for drugs (opioids) including generic opioids and recent approvals for pain management.

In this 60-min presentation, the speaker will guide you through the details of FDA roles, regulations, generic opioids and recent FDA approvals for chronic pain management.

About the Areas to Be Discussed

  • FDA Laws and Regulations
  • Definitions
  • Learn About Controlled Substances
  • Regulation of Abuse-Deterrent Opioid Medications
  • Opioid Misuse & Abuse
  • Prevention of Opioid Abuse and Appropriate Pain Management
  • New Labeling Requirements
  • FDA Approved Generic Opioids
  • Recent FDA Approvals for Pain Management Drugs
  • Best Practices

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Medical Doctors and Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. 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 use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA 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.  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.

Registration Options

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $799 

LIVE (≥ 5 attendees): $999 

LIVE & Recorded$399 

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
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
Sep
3
Tue
Understanding Pain Management and Opioids
Sep 3 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Understanding Pain Management and Opioids: FDA Regulations, Generics and Recent Approvals

  • Date: June 4, 2019
  • NOTE: This seminar recurrs tri-monthly (every three month) on 1st Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes

About the Seminar

Pain Management OpioidsThe United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities.

Opioids as prescription drugs are used to reduce chronic pain.  Opioids offer both great benefits and also serious risks, potentially causing serious harm (addiction, overdose and even death) when misused or abused.

This seminar is intended to help industry and professionals to better understand FDA roles and regulation governing controlled substances (opioids) used for pain management. This seminar is also intended to help industry get better familiar with FDA’s recent activity and regulatory expectations  for drugs (opioids) including generic opioids and recent approvals for pain management.

In this 60-min presentation, the speaker will guide you through the details of FDA roles, regulations, generic opioids and recent FDA approvals for chronic pain management.

About the Areas to Be Discussed

  • FDA Laws and Regulations
  • Definitions
  • Learn About Controlled Substances
  • Regulation of Abuse-Deterrent Opioid Medications
  • Opioid Misuse & Abuse
  • Prevention of Opioid Abuse and Appropriate Pain Management
  • New Labeling Requirements
  • FDA Approved Generic Opioids
  • Recent FDA Approvals for Pain Management Drugs
  • Best Practices

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Medical Doctors and Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. 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 use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA 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.  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.

Registration Options

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $799 

LIVE (≥ 5 attendees): $999 

LIVE & Recorded$399 

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
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
Dec
2
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Dec 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