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.
March 3, 2020
10:00 AM PST | 01:00 PM EST
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Product Id : 502881
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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:
Who Will Benefit:
- 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
- Regulatory Affairs
- Supply Chain
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.