2013-09-24 16:53:20 - FDA Recordkeeping, Dangerous Documents and Writing for Compliance ™
**Presented by FDAnews**
Nov. 13-14, 2013 – Bethesda, MD
Every day, we 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 you don’t need to be afraid to write your next email. Join us on Nov. 13-14 for a two-day intensive workshop: FDA Recordkeeping, Dangerous Documents and Writing for Compliance ™
This is not your
Instead of sitting and being lectured to, you will engage in case studies, role playing, real-life examples and exercises designed to ensure that your written word not only properly reflects your compliance initiatives, but also prevents trouble. You’ll 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 - You will receive a USB drive that contains more than 100 checklists, SOPs, cheat sheets, ready-to-use forms, policy papers, guidances, articles and more.
60 Years of Experience
Our 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. His latest book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, has garnered multiple five-star reviews. He has a breadth of experience designing, implementing and being accountable for quality systems and compliance programs for FDA, DEA, ICH, GHTF/IMDRF and ISO. For more than 15 years, he was directly accountable for regulatory compliance, records management and information technology, most recently as a C-level executive for a Fortune 50 combination device subsidiary.
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. She was a member of the FDA/industry working group that established initiatives to improve the efficiency and transparency of the FDA inspectional process. She began her career as an attorney with the United States Department of Justice litigating FDA enforcement cases, and then served as a partner at the Washington law firm of Kleinfeld, Kaplan and Becker. Later she served as General Counsel to Lansinoh Laboratories. She also chaired the Food and Drug Law Section of the Federal Bar Association.
John “Jack” Garvey is the founder of Compliance Architects. A leading FDA regulatory, compliance and operations executive with more than 25 years of experience developing and leading quality, regulatory and compliance initiatives, Mr. Garvey focuses on compliance and quality strategy development and deployment for leading life-science companies. A dual background in law and engineering gives his clients an advantage in resolving complex regulatory, quality and compliance issues.
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. They 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 at www.fdanews.com/DangerousDocsPR5
for the complete workshop.
EASY WAYS TO REGISTER
By phone: 888-838-5578 or 703-538-7600