Thursday, August 23, 2012; 1:00 – 2:30pm EDT (GMT -4)
FDA investigators are now evaluating firms’ record retention policies, and observations of inadequate document retention policies have appeared on many 483s. Firms have even received Warning Letters citing their record retention policies, including the one excerpted here:
"Appropriate record retention policies should also be in place. Our inspection reported that your firm has destroyed some old, but foundational records for your products. We recommend that your firm reconsider your record retention policy..."
This Warning Letter continues, elaborating on some of the procedures FDA expects a firm to establish: "...providing reasonable assurances to the Agency regarding a product and integrity of data submitted to support it. Such a document management program should also include a document destruction procedure that ensures documents are destroyed in a controlled manner. This would include, at a minimum, identification of the appropriate documents and retention timelines, documentation of what was destroyed, and the names and signatures of those who witnessed the destruction'."
While FDA specifies some records be maintained for a defined interval, other records may be freely discarded; Part 11 adds additional requirements for electronic records. In many cases the regulations are silent – but it is clear from 483s and Warning Letters that companies must have written record retention procedures.
Where do you start in developing a records retention policy that meets FDA's expectations? On Thursday, August 23 beginning at 1:00pm EDT, join FOI Services for a 90-minute teleconference during which a former FDA investigator, a former Philip Morris tobacco litigation records director, and a former FDA prosecutor will talk about how companies should handle their internal documents and set up their document retention standard operating procedures.
Questions to be Addressed Include:
- Which types of documents are companies required to create under the Federal Food, Drug and Cosmetic Act?
- What are the key elements of an SOP on good documentation procedures?
- How do companies figure out how long they have to keep records?
- What is a dangerous document?
- How have companies and individuals been embarrassed by statements in documents?
- Why do prosecutors, investigators, plaintiff lawyers and juries take a negative view of inconsistent document practices?
- What kinds of document retention mistakes do quality and regulatory affairs departments tend to make?
- What are the rules for destroying documents not required by government regulations?
- How can destroying too many documents get you in trouble?
- How can firms set up a good document retention program?
- How can record retention questions be incorporated in your audits of CMOs, CROs and distributors?
- How can companies get cooperation from employees and onsite contractors to follow the program?
- What do FDA investigators expect to see when they ask for complete and accurate records during an inspection?
- How long will an investigator wait for a company to locate a record?
- Will FDA automatically cite a firm for not being able to locate a record?
- Can a document retention program help a firm improve its compliance profile?
What You'll Get:
- A sample checklist with a 27-point records retention self-assessment questionnaire (perfect for adopting into CMO and CRO qualification audits)
- Two article reprints on record integrity considerations for FDA-regulated firms
- An opportunity to receive a 4-month trial subscription to the FDA regulatory intelligence newsletter, SmarterCompliance
- Access to experienced and knowledgeable experts
- Time for questions and answers
Who Will Benefit:
- Regulatory affairs directors and managers
- Quality assurance directors and managers
- Legal professionals
- Compliance officers
- Record and document archivists
- Information center managers
- Everyone responsible for maintaining long-term document and record integrity
About Your Presenters:
John Avellanet has spent over 15 years being responsible for regulatory compliance and information management. During his career, he built and ran document retention and IT departments, including those for firms under litigation and government investigation. Over the past decade, he has repeatedly been relied upon by attorneys to scrutinize and audit non-compliant records management programs, policies and SOPs. Since founding his FDA compliance firm, Cerulean Associates LLC, he has worked with multiple pharmaceutical and medical device clients to develop and strengthen document retention programs to pass FDA, EMA and Health Canada inspections.
Rhona Shanker spent 22 years FDA, where she began as an investigator in FDA’s Baltimore District auditing food, drug, device, biologic and cosmetic firms to assess their compliance with applicable FDA regulations. Ms. Shanker then moved to the Office of Compliance in the Center for Devices and Radiological Health where she worked with FDA field offices to put together cases that resulted in seizures, injunctions, civil penalties and other legal actions, including precedent-setting cases for the Center. Since leaving FDA, Ms. Shanker has begun consulting with regulated industry in order to help them successfully comply with FDA pre- and post-market regulations.
Nancy Singer is the president of Compliance-Alliance LLC, a firm specializing in professional development for those employed in drug, device and other manufacturing industries. She teaches FDA and industry officials to create complete and accurate documents that will not be misinterpreted. Ms. Singer's career began as an attorney with the United States Department of Justice where, during a three year period, she successfully prosecuted seven firms for violations of various criminal statutes. Subsequently, she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Ms. Singer received her B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School.