Browsing Category Archived Recordings

The Hitchhiker’s Guide to 483s and Warning Letters – 2015 Archived Recording Download

  In this light, entertaining but rigorous Webinar by Angela Bazigos, CEO Touchstone Technologies, presenter of our other excellent webinar on writing FDA compliant SOPs, you will learn the very latest in FDA compliance trends, how to respond to an FDA 483 and warning letter, and how to prevent them from occurring at all. Any [...]

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Category : Archived Recordings

How to Survive Your Next FDA Inspection – 2015 Archived Recording Download

  How The Quality Manager Gets Fired, aka The $50,000 Compliance Mistake: You’ll learn about this in the Webinar below, but here’s a hint – You have 15 days to respond to a 483, or else! Miss the deadline, and your FDA 483 response is for naught! It sounds obvious, but this huge costly mistake [...]

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Category : Archived Recordings

FDA Update on Consent Decrees and Criminal Prosecutions | Sheldon Bradshaw | Archived Recording

CD or Download Available! FDA has been enforcing cGMP guidelines for drugs and medical devices more strictly than ever in recent years. One of the ways it is increasing enforcement is through the issuance of consent decrees. Former FDA Chief Counsel Sheldon Bradshaw provides an update on FDA’s more aggressive stance on consent decrees and [...]

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Category : Archived Recordings

Update on FDA’s Aggressive, New Enforcement Policies | Sheldon Bradshaw | 2011| Archived Recording

Archived Recording – CD and download available! FDA is now strongly committed to more and stronger FDA enforcement. Learn how new FDA leaders are increasing enforcement actions. What You Will Learn in This FDA Enforcement Update: FDA is getting more aggressive in the following ways: Set post-inspection deadlines.  FDA will give regulated industry no more [...]

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Category : Archived Recordings

How to Write FDA-Compliant SOPs | Oct. 9, 2013, 1 PM EDT | Bazigos

Standard Operating Procedures (SOPs) are required according to FDA cGMP regulations for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet, surprisingly, there  is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult [...]

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Category : Archived Recordings

How To Negotiate Clinical Trial Contracts – Stark Rule, Anti-Kickback, and False Claims Act | Archived Recording| Romanchuk|

Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements This webinar will give you a solid grasp of the regulations and statutes that anyone involved in clinical research contract negotiation has to know. You will discover how to negotiate and make clinical trial agreements that are federally compliant, thus avoiding [...]

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Category : Archived Recordings

FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters | Archived Recording| Bradshaw

FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters | Archived Recording| Bradshaw

Archived Recording – CD and download available! Getting an FDA warning letter can cost you big. Your company can receive bad publicity and lose business. Your reputation suffers, and in some cases, your firm may even have to deal with FDA’s Office of Criminal Investigation. Join us and learn from former FDA Chief Council Sheldon [...]

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Category : Archived Recordings

How to Prepare Yourself for 21 CFR Part 11 Inspections| Archived Recording| Avellanet

CD or Download Recording Available! FDA announced in 2012 that it will soon begin to conduct 21 CFR Part 11 inspections. Are you ready? In this Webinar, John Avellanet will detail how to prepare yourself for coming Part 11 audits by FDA, as well as how to comply with the revised EMA Annex 11. What [...]

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Category : Archived Recordings

Avoiding Warning Letter Disasters With a Strong cGMP Quality Agreement| Archived Recording|Minsk

Avoiding Warning Letter Disasters With a Strong cGMP Quality Agreement| Archived Recording|Minsk

CD or Download Recording Available!   In his 9th appearance in this highly praised webinar (see feedback below), discover a potential table of contents for your cGMP or GCP quality agreement, why you must use FDA defined terms where they exist. Learn the obligations for all stakeholders under a quality agreement, how to develop your [...]

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Category : Archived Recordings

Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission| Archived Recording|Azevedo

CD or Download Recording Available! FDA eCopy Webinar Overview eCopy is a new electronic submission requirement for most drug applications that has been in effect since the beginning of 2013. Our April 10 Webinar on eCopy was very well received, and addressed many of the confusing and contradictory aspects of eCopy. There have been many [...]

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Category : Archived Recordings

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