Speaker Profile


Dr. David Lim

President and Principal Consultant, REGULATORY DOCTOR

Dr. David Lim , Ph.D., RAC, ASQ-CQA.is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker,He frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, 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 eight 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 has contributed to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals at the Regulatory Doctor.

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  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
GCP-GLP-GMP : Comparison and Understanding of FDA's 3 Major Regulations

For manufacturers for drugs, biologics, biosimilars, generics, and medical devices, firms are subject to various statutory and regulatory requirements under FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). To provide safe and effective medical products, it is important for the FDA-regulated industry to accurately understand and apply the applicable regulations and requirements under GLP, GCP and GMP.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $390.00
GCP-GLP-GMP : Comparison and Understanding of FDA's 3 Major Regulations

For manufacturers for drugs, biologics, biosimilars, generics, and medical devices, firms are subject to various statutory and regulatory requirements under FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). To provide safe and effective medical products, it is important for the FDA-regulated industry to accurately understand and apply the applicable regulations and requirements under GLP, GCP and GMP.

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