LIVE Online Seminar

Good Clinical Practice (GCP) for Drugs, Biologics and Medical Devices Including IVDs

Virtual Meeting
GCP Training (LIVE Online Seminar)

About the Seminar

This GCP training seminar is intended to help global healthcare industry professionals get familiar with Good Clinical Practice (GCP) applicable for drugs and medical devices during clinical trials, investigations and studies.

This seminar consists of five (5) modules.  Each module is a 60-min presentation (either LIVE or recorded).

NOTE: LIVE seminars are offered with flexible schedules.

About the Areas to Be Discussed

  • Module 1:
    • US Laws and Regulations
    • Definitions
    • GCP Guidance Documents (FDA, ICH-E6, MEDDEV, IMDRF/GHTF)
    • ISO Standards
    • Labeling Requirements
  • Module 2:
    • Clinical Trials Requirements
    • Sponsor: Requirements
    • Institutional Review Boards (IRBs): Requirements and Guidance
    • Clinical Investigators: Requirements and Financial Disclosures
    • Informed Consent Elements/Requirements/Exception/Guidance
    • CROs, CRAs, and Consultants
    • Form FDA 1572: Statement of Investigator
  • Module 3:
    • Drug Clinical Trials: Study Design, Study Subjects and Tests
    • IND: Contents and Format
    • Emergency Use and Treatment Use of an Investigational Drug or Biologic
    • Domestic Clinical Trials
    • Foreign Clinical Trials
    • Common Mistakes/Deficiences
    • Clinical Hold
  • Module 4:
    • Significant Risk and Nonsignificant Risk Medical Device Studies
    • IDE: Contents and Format
    • Common Mistakes/Deficiences
    • Clinical Hold
  • Module 5:
    • FDA BIMO Inspection
    • Preparing for an FDA BIMO Inspection: Dos and Don’ts
    • Documentation Requirements

About the Intended Attendee(s)

  • Regulatory affairs
  • Marketing
  • Clinical Affairs
  • Quality
  • Legal Counsel
  • Compliance Officers
  • Consultants
  • Regulatory Agency Personnel
  • Any Professionals Interested in the Topic

About the Seminar Speaker

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) 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 and 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. Dr. Lim serves as a member of the advisory board for inspection insider at FDA News. Dr. Lim also contributes to FDA Guidance.net, providing FDA guidance information for free to the FDA regulated industry.

  • To learn more about Regulatory Doctor, click here.

Registration 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 contact us below

Share