Production Records Tell the Story to the FDA and the Public, Are They Accurate? Production Information Management GMPs and Risk Management

Event Information
Product Format
Prerecorded Event
60 Minutes
Product Description

Accurate Production Records: Mind These Information Management GMP’s & FDA Regulations

Company production records are a snapshot of performance and performance, in turn, determines market value. The government determines regulatory compliance from production records.

Are your company production records complete and accurate? Are Information Management GMP’S followed? How is your company making the transition to electronic records, per FDA regulations? When was the last time your company trained on production records, with these values in mind?

Get answers to all these questions and much more with our expert presenter Kenneth N. Rashbaum. This power packed webinar will provide you with the following:

  • Review of Production Record and Information Management GMP’s and FDA regulations
  • Review of recent FDA actions based on inaccurate production records
  • Risk analysis for production records and electronic communications about production
  • Template for company training on Production Record GMP’S , FDA regulations and transition to electronic records

Here are few topics covered in the session:

  • Company performance is indicated by production records. Are they accurate and complete?
  • Signature: Verifies Accuracy and Completes the Record of What Was Done
  • Know how records are evidence of regulatory compliance - or non-compliance
  • How can an accurate and complete production record act as defense to law suits against the company
  • How the transition to electronic records will change the paradigm of compliance
  • Electronic communications (email, texts, blog posts, and social media) are “records,” too, and will be considered by the markets and the government. These records can be used as evidence. Do you have a policy on these communications?
  • Federal law documentation standards -  CFR 211.100 Written Procedures, Deviations
  • Key To Defensible Processes and Risk Management
  • Investigation: Potential Root Causes & Potential Consequences
  • Legal: Product Liability, The Deposition & Law Suit Development
  • Additional Case Studies & Teachable Moments
  • And much more…

Who should attend? Plant Managers, Risk and Compliance Officers, Training Managers, Production Managers, General and Assistant General Counsel, IT Managers, Records Managers

Order Below or Call 1-866-458-2965 Today

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About Our Speaker

Kenneth N. Rashbaum

As a litigator, trial lawyer and counselor, Kenneth N. Rashbaum has been the trusted advisor to pharmaceutical and biotech companies, healthcare providers, health plans and multinational corporations on information governance and its compliance with federal, state, and international law, and the interface of electronic information of legal and regulatory liabilities. He has served as partner and Co-Chair of the E-Discovery, Compliance and Data Management Practice Group of AmLaw 100 law...   More Info
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