FDA Regulations Governing GCP, GLP and GMP

  • Speaker:Dr. David Lim
  • Duration:60Min
  • Product Code:GRC-90069

Live Session - How it works

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Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

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 Description:

It is important for the FDA-regulated industry to better understand applicable FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) for drugs, biologics and medical devices including in vitro diagnostics (IVDs).
This webinar is intended to help the FDA-regulated industry get better familiar with the GLP, GCP and cGMP requirements from regulatory and compliance perspectives.
Good understanding and adequate implementation of the regulatory requirements under GLP, GCP and cGMP regulations are critical to make better, informed business and regulatory decision.  Adequate awareness can greatly help firms save a significant amount of various business resources.
In this presentation, the speaker will discuss FDA regulations including key provisions and requirements governing GCP, GLP and GMP applicable to drugs, biologics and medical devices including IVDs.

Areas To Be Covered in this Webinar:

•    Laws and Regulations
•    Definitions
•    Good Laboratory Practice (GLP): Regulation and Important Requirements
•    Good Clinical Practice (GCP): Regulation and Important Requirements
•    Regulations for Current Good Manufacturing Practice (CGMP) for Food, Drugs, Biologics and Medical Devices
•    FDA Guidance(s) and Standard(s)
•    Best Practices When Implementing GLP, GCP and GMP: Dos and Don’ts
•    Speaker’s PASS-IT Recommendations

Who will benefit:

•    Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
•    Compliance Officers
•    Regulatory Affairs
•    Clinical Affairs
•    Quality Assurance
•    Laboratory Personnel
•    IT Professionals
•    R&D
•    Consultants
•    Contractors/Subcontractors
•    Other professionals interested in this topic

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us).  As a leading industry speaker, Dr. Lim 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 contributes 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 being conducted at the Regulatory Doctor. 

Available Options

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,659

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,459

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