Browsing 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

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

Spend $500K on Compliance or $300 Million for Consent Decree? – Essential cGMP Compliance Tips for Sr. Management| Archived Recording | Avellanet

Spend $500K on Compliance or $300 Million for Consent Decree? – Essential cGMP Compliance Tips for Sr. Management| Archived Recording | Avellanet

CD or Download Archived Recording Available! Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements   Free Webinar CD and Download Recording Included! Learn how your senior management team can management FDA compliance effectively with just 48 hours per year. Discover 14 typical FDA auditor questions regarding quality systems management, [...]

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Category : Archived Recordings

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