Webinar Information

FDA Audit - Responsibilities of the Auditor and Responsibilities of the firm

Webinar Title
FDA Audit - Responsibilities of the Auditor and Responsibilities of the firm
Event Type
Webinar Date
Last Date for Applying
Fremont, California, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Organizing/Related Departments
Online Training
Organization Type
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries


Business Development




Fremont, California, United States


The presentation will include the types of audits that could occur.

What happens when you receive an audit off shore vs. within the US. How do you prepare for these audits? What must be done prior to the audit? What happens during the audit? What happens after the audit? How do you respond? What happens differently if a consultant is involved?

Why you should Attend: Why attend? The biggest fear that we have is undergoing a regulatory audit. What will they find? Will they find something that we overlooked? Could what we overlooked cause us to lose our ability to work in this industry? So what can we do to prepare for the audit, how can we ensure a smooth audit, and what happens after the audit.

Areas Covered in the Session:

  • Audit requirements for the Auditor
  • Audit requirements for the Firm
  • Specifics on regulations for the audit
  • Do's and Don't's during the audit

Who Will Benefit:

  • Quality
  • Manufacturing
  • Regulatory Affairs
  • QA/QC/RA
  • R&D
  • Supply Chain
  • Purchasing



Speaker Profile

Courtland Imel is CEO of Ceutical Laboratories. Courtland has provided training to FDA, Health Canada, and state regulatory authorities. Courtland has spoken at AFDO, AFDOSS, MCAFDO, ASQ, SCC, and Bio. Courtland has 35 years of experience in the industry. Courtland is an SME for several organizations and law firms. Courtland worked for M&M Mars, Allergan, ILEX Oncology, Aronex Pharmaceuticals, Mills Biopharmaceuticals, International Isotopes, Avail Medical Products, Carrington Laboratories, and Ceutical Laboratories, Inc. Courtland has assisted in the submissions of 510Ks, PMAs, IND’s, NDAs, ANDAs, IDEs, and more.

Ceutical Labs provides many services including product development, formulation development, analytical testing (chemistry, microbiology, and physical), regulatory submissions, electronic submissions, consulting, training, quality systems, and more.


Event link:


Contact Info

Netzealous LLC, DBA -Compliance4all

Email: [email protected]

Phone: +1-800-447-9407

Website: https://www.compliance4all.com/

Others Details

Contact Info Netzealous LLC, DBA -Compliance4all Email: [email protected] Phone: +1-800-447-9407 Website: https://www.compliance4all.com/

Registration Fees
Registration Fees Details
Registration Ways
Online  Pin/Zip Code : 94539
Official Email ID
Netzealous LLC,DBA -Compliance4all


[email protected]

   8004479407    Fax No: 94539