Creating Simple, Defensible Documentation to Prove FDA Compliance
Presented by Nancy Singer, Compliance-Alliance & John Avellanet, Cerulean Associates LLCThursday, June 14, 2012; 1:00pm – 2:30pm EDT -4 (GMT -4)
FDA investigators don't care what you say you do.
The ugly truth is that FDA only considers your firm to be in compliance if you can produce the records which prove your firm followed its procedures and complied with FDA requirements.
To an FDA investigator, if it isn’t recorded, your compliance is only a rumor.
If your firm is like most, you have carefully-prepared, elaborate, detailed procedures on paper. They look terrific, are up-to-date with FDA requirements and have been distributed to all the right people. And just like most companies, you often face a problem…your staff may fail to follow procedures.
Why are procedures not absorbed and records of the resulting compliance overlooked? Are your procedures too prescriptive, discouraging busy people from following them? Are your procedures too generic and high-level, offering no real guidance for identifying important information? How do you strike a balance? How do you keep staff on task, on procedure, on target and on record to prove compliance with FDA's requirements?
On Thursday, June 14 beginning at 1:00pm EDT, join FOI Services for a 90-minute teleconference: "Creating Simple, Defensible Documentation to Prove FDA Compliance." During this session, John Avellanet of Cerulean Associates LLC and Nancy Singer of Compliance-Alliance will explain how you can create simple yet comprehensive Standard Operating Procedures and documentation to help you demonstrate your firm’s compliance with the rules established by FDA and other regulatory agencies.
What You Will Learn:
- 6 activities involved in complying with regulatory requirements
- Techniques to answer "What is the right way?" to comply
- Indispensable references
- Do's and dont's for using off-the-shelf templates for your procedures
- How to determine if a consultant's interpretation of the requirements is accurate
- How you can get buy-in for compliance with regulatory requirements
- Tips for establishing levels of documentation
- How to develop a matrix to show regulatory compliance
- Ways to use process mapping to create procedures
- Techniques to develop procedures for a globally harmonized system
- A simple set of metrics to gauge the compliance comprehension of your SOPs
What You'll Get:
- Links to references for regulatory compliance
- Sample warning letters and 483 observations for failure to adhere to SOPs
- Sample matrix to show regulatory compliance
- Defensible SOP template designed for compliance
- An option to receive a six-month trial subscription to the FDA intelligence newsletter, SmarterCompliance
- Experienced & approachable instructors
- Time for questions and answers
Who Should Attend:
- Quality assurance/quality control
- Regulatory affairs
- Research and development staff
- Management personnel
- Technical writers
- Legal affairs
- Documentation specialists
About Your Presenters:
John Avellanet spent over 15 years being accountable for regulatory compliance, most recently as a C-level executive for a Fortune 50 biotechnology and medical device subsidiary. In 2006, John co-founded his FDA management advisory firm, Cerulean Associates LLC. He is the author of more than 100 internationally syndicated articles on simplifying compliance and FDA quality systems, is the compliance columnist for the Journal of Commercial Biotechnology and for Pharmaceutical Processing magazine. He conducts on-site and remote corporate workshops for his clients, and has led dozens of training seminars on FDA quality systems, records management, and lean compliance. He has a straightforward and real-world teaching style, consistently garnering "Excellent" and "Wow" evaluations from attendees. You can learn more about John’s background by visiting www.ceruleanllc.com.
Nancy Singer founded Compliance-Alliance LLC (www.compliance-alliance.com) to specialize in professional development for those employed in the drug and medical device industries. Previously, she was the founder and the Executive Director of the Medical Technology Learning Institute, the educational entity within AdvaMed established to provide training on FDA/CMS regulatory requirements. She also served as AdvaMed's Special Counsel for FDA compliance and enforcement matters. Notably, in her role as Special Counsel, Nancy represented the industry on the working group that conceived the Quality System Inspection Technique (QSIT) and later served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry. Before joining AdvaMed, Nancy was the Executive Director of the Food and Drug Law Institute. Her career began as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration.
How It Works:
Each toll-free (even if international) dial in is $449; put the teleconference on your speakerphone and have as many attendees as you like for this price. FOI Services will provide a handout 1-2 days before the teleconference. The materials may be duplicated for anyone attending.
When:
Thursday, June 14, 2012, 1:00pm – 2:30pm EDT