Avoid Documentation 'Time Bombs'

This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Sep-2019

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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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
Instructor Profile:
John E Lincoln 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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