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

The presentation will include FDAs recent guidance document on supply chain for Compounding Pharmacies and how others can use these same standards.

Courtland Imel
Courtland Imel
Tuesday, March 3, 2020
10:00 AM PST | 01:00 PM EST
60 Minutes

More Trainings by this Expert   Product Id : 502881

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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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 should you 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.

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