This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.
Your own communications and documents can be used against you.
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 seminar:
- 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
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
