Toll Free: +1-888-717-2436


Your Shopping Cart

Contains 0 items
Total: $0.00
View Shopping Cart
Cart Image

customer care
Fax: +1-650-963-2556
Read Frequently Asked Questions

Preparing for a U.S. FDA Audit

Buy Now Section

How to create and blend the Risk Management File findings into the company’s internal and external audit plans?

Instructor: John E Lincoln
Product ID: 700816

Structured, defined and tested CGMP systems are the start in successfully passing the "real thing". Increasingly such systems are to be risk-based, as stated by the US FDA and the EU. So, where does a company look to ensure their compliance is structured and prioritized by risk? How to create and blend the Risk Management File findings into the company’s internal and external audit plans? How is it established, maintained, formally updated, and documented? Learn from others mistakes - current FDA 483 observations. The receptionist - an auditor’s first company contact. Strategic perception. Arrangements for and facilitation of the outside audit. Training personnel on how to be "audited". Close outs "musts". Where and how to draw the "line in the sand". Responses - how, what, frequency. Avoiding Warning Letters.

Areas Covered in the seminar:

Who will benefit:

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 27 years of experience, primarily in the medical device industry.

Follow us :
Bookmark and Share
Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email or call +1-888-717-2436(Toll Free).

COSO Framework for Internal Controls, Risk Assessment and Financial Statement Audit - 80225SEM

This training hasn't been reviewed yet.

Review this training

Training Options Training Duration = 60 Min
$249.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$500.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days