6-Hour Virtual Seminar

6-Hour Virtual Seminar on Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties

  • Friday
  • June
  • 25
  • 2021
Time:
08:00 AM PDT | 11:00 AM EDT
Duration:
6 Hours
Angela Bazigos Instructor:
Angela Bazigos
Webinar Id:
50633

More Trainings by this Expert

Price Details
$545 Live
$745 Corporate Live
$595 Recorded
$945 Corporate Recorded
Combo Offers
Live + Recorded
$912 $1140 Live + Recorded
Corporate (Live + Recorded)
$1352 $1690 Corporate
(Live + Recorded)
Price Detail Options
Overview:

The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc.

These regulatory actions can have significant financial impact to the company. However, and most importantly, Data Integrity issues can lead to potential patient harm!!

To ensure Data Integrity, a GxP regulated company needs to abide by principles, current regulations and industry best practices on the expectations for the management GxP regulated records and data. These principles, regulations and best practices, ensure that data is complete, consistent, accurate, secure and available throughout the record life cycle.

This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality, patient safety and public health.

Why you should Attend: This virtual seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where Data Integrity is important. It provides a method for managing risk to record and Data Integrity.

Agenda:

  • Data Integrity Framework
  • Quality Risk Management
  • Data Life Cycle
  • Data Integrity Management
  • Auditing & Audit Trails
  • Data Integrity for Electronic Records / Electronic Signatures (ERES)

Who Will Benefit:
  • VP of IT
  • Director of IT
  • Quality Managers
  • Project Managers (for CSV / IT)
  • Validation Specialists
  • Database Administrators
  • System Administrators
  • Directors / Senior Directors of Discovery
  • Directors / Senior Directors of Development
  • Directors / Senior Directors of Commercialization
  • Document Managers
  • Training Managers
  • Regulators
  • Vendors
  • Suppliers
  • Outsource Service Providers


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.


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