FDAnews Announces: FDA Recordkeeping, Dangerous Documents and Writing for Compliance ™, Nov. 13-14, Bethesda, MD

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It's no longer enough to set up an effective FDA documentation program. Discover how to ensure that written correspondence reflects compliance initiatives through case studies, role playing, real-life examples and exercises.

FDA Recordkeeping, Dangerous Documents and Writing for Compliance

FDA Recordkeeping, Dangerous Documents and Writing for Compliance

“Dangerous Documents is a fantastic presentation, filled with real-world examples of what not to do.” -- Senior Regulatory Affairs Specialist, ACell, Inc.

FDA Recordkeeping, Dangerous Documents and Writing for Compliance ™
**Presented by FDAnews**
Nov. 13-14, 2013 – Bethesda, MD

Every day, people write casual emails, meeting minutes and sticky notes, never anticipating that an FDA inspector or other third party will read them. But these are exactly the types of correspondences that are often used to determine an organization’s overall compliance profile.

And thanks to product liability lawyers, these notes also need to be defensible…from criminal actions and lawsuits. A simple and harmless phrase such as “This will negatively impact our bottom line,” can be the key piece of evidence against you in a product liability case.

But don’t be afraid to write the next email. Join FDAnews on Nov. 13-14 for a two-day intensive workshop:FDA Recordkeeping, Dangerous Documents and Writing for Compliance™.

This is not a typical workshop

Instead of sitting and being lectured to, participants will engage in case studies, role playing, real-life examples and exercises designed to ensure that the written word not only properly reflects compliance initiatives, but also prevents trouble. Attendees will leave this workshop knowing:

  • Who in your company could be held criminally liable for record deficiencies
  • Core requirements for keeping records
  • Questions FDA investigators ask to determine the trustworthiness of records
  • Expectations for digital versus paper records
  • Email’s risks
  • How to establish an effective records retention schedule
  • Proper ways of handling supplier and CAPA records
  • How to balance long-term storage challenges — paper and digital
  • FDA-approved techniques for disposing of records

BONUS - Attendees will receive a USB drive that contains more than 100 checklists, SOPs, cheat sheets, ready-to-use forms, policy papers, guidances, articles and more. Click here for a full list.

60 Years of Experience

The panel of speakers consists of three of the industry’s most sought-out consultants and experts, with a combined 60 years of experience. They include:

John Avellanet, founder of an independent compliance consulting and training firm, Cerulean Associates LLC. He has earned international acclaim for his pragmatic FDA compliance advice.

Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for FDA and industry staff. Previously she served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters.

John “Jack” Garvey is the founder of Compliance Architects. He is a leading FDA regulatory, compliance and operations executive with more than 25 years of experience developing and leading quality, regulatory and compliance initiatives.

The Benefits of Attending

This informative conference will benefit drug, biotechs, biologics, diagnostics, cosmetics and device companies, as well as food and tobacco companies and any other organization regulated by the FDA. Attendees will include executive management, regulatory affairs personnel, quality assurance/quality control managers, legal and compliance officers, and directors of clinical research. Attendees will learn:

  • How to distinguish between fact and opinion
  • Who should avoid writing opinions on regulatory matters
  • The unrecognized dangers in casual emails
  • The information to include and exclude when writing meeting minutes
  • The problem with writing documents in the passive voice
  • How sticky notes on files can cause trouble for companies during a lawsuit
  • Words that will attract the attention of prosecutors or plaintiffs’ lawyers if a company is sued
  • How to write documents to reflect the company’s compliance activities

Register now. The complete workshop is only $1,797.

FDA Recordkeeping, Dangerous Documents and Writing for Compliance ™
**Presented by FDAnews**
Nov. 13-14, 2013 – Bethesda, MD

TUITION: $1,797

Online:     http://www.fdanews.com/FDARecordkeeping
By phone: 888-838-5578 or 703-538-7600

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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