FDA Inspection Policy and Best GMP Practices

  • Speaker:Dr. David Lim
  • Duration:60Min
  • Product Code:GRC-90173

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

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.

(For more information about our products contact +1- 248-233-2049)

Description:

This seminar will discuss what FDA-regulated industry should know about FDA’s current inspection policy to adequately implement the Good Manufacturing Practices (GMPs). The common GMP deficiencies cited in 483s issued to medical device and pharmaceutical manufacturers will be discussed. The most common deficiencies are based on the speaker’s analysis of 483s issued for the past eight (8) years.

This presentation will greatly help you better prepare for and manage an FDA inspection in a proactive and effective manner.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.  

This presentation will provide great opportunities to become familiar with the FDA inspection policy and industry’s best GMP practices including the lessons learned from the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

The speaker will share his PASS-IT recommendation/suggestions. 

Areas To Be Covered in this Seminar:


•    Applicable Laws and Regulations
•    FDA Manuals and Inspection Guides
•    Inspection Types and Categories
•    Inspection Classification
•    FDA Forms 482 and 483
•    Common Deficiencies
•    What/How to Prepare for and Manage an FDA Inspection
•    How to Communicate Before, During and After inspection: Dos and Don’ts
•    Inspection Preparation Procedures
•    Recent Trends
•    Responding to 483s, If Issued
•    How to Communicate with Emotional Intelligence
•    Employee Training
•    Actual Case Studies
•    Speaker’s PASS-IT Recommendations

Who will benefit:


•    CEOs
•    VPs
•    Compliance Officers
•    Attorneys
•    Regulatory Affairs
•    Clinical Affairs
•    Quality Assurance
•    R&D
•    Consultants
•    Contractors/Subcontractors
•    Anyone Interested in the FDA Drug Review and Approval Processes

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. 

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$289

CD-DVD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$429

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

$2,549

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

$3,569

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