Avoid Documentation 'Time Bombs'

Why Should You Attend:

Lab books, project and design history files, correspondence including e-mails, websites, and marketing literature may all contain information that can compromise a company and it's regulatory compliance. Major problems with the U.S. FDA and/or in lawsuits have resulted from careless or inappropriate comments or even inaccurrate opinions being "voiced" by employees in controlled or retained documents. Opinionated or accusatory E-mails have been written and sent, where even if deleted, still remain in the public domain where they can effectively "last forever".

In this electronic age of My Space, Face Book, Linked In, Twitter, Blogs and similar instant communication, derogatory information about a company and its products can be published worldwide, and "go viral", whether based on fact or not. Today one's 'opinion' carries the same weight as 'fact'.

But do companies and their employees realize:

• How long lasting such communication really is; and
• The regulatory ramifications of such communications. Even the older, hard copy documentation may contain hidden landmines: Lab books, SOPs, drawings and specifications, project and design history files and even technical files / design dossiers. What are such "landmines"? How can they be reduced? Why should companies / employees care?

Attend this documentation training to know the answers to above questions.

Areas Covered in the Webinar:

• The problems.
• Electronic "eternity".
• Hard copy headaches.
• Regulatory issues.
• Potential legal issues for non-lawyers.
• Solving the problem - steps to take.
• Monitoring effectiveness -- integration of corrective / preventive action.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to be aware of the pitfalls of careless, "stream of consciousness" in appropriate conversation and electronic or written opinions. Once recognizing the danger and likely locations, then putting in place the necessary policies and training to minimize their occurrence. This information applies to personnel / companies in the Medical Device, Diagnostic, and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering
• All personnel involved in documentation or having access to e-mail / the Internet

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

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