FDAnews Announces — Training Staff to Detect Data Integrity Issues Webinar, Sept. 27, 2016

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Even the most seemingly minor misstep in recording data can land a company in a world of hurt — failed inspections, warning letters, recalls, loss of profit and reputation, and more. Join industry experts Susan J. Schniepp and Linda Biava for the Training Staff to Detect Data Integrity Issues webinar on Sept. 27 when they discuss training staff in detecting data integrity issues.

Training Staff to Detect Data Integrity Issues
**An FDAnews Webinar**
Sept. 27, 2016 — 1:30 p.m. – 3:00 p.m. ET
http:// [http://info.fdanews.com/training-staff-to-detect-data-integrity-issues-pr

Even the most seemingly minor misstep in recording data can land a company in a world of hurt — failed inspections, warning letters, recalls, loss of profit and reputation, and more.

Think about all the people in your organization who have responsibility for recording data. Do they know how to do it correctly? Do they understand the potential consequences of ignoring the rules of documentation? Can you see how critical it is that they do?

Ensuring data integrity is not just compliance with 21CFR Part 11 anymore. Want to leave it to chance that you’ll be OK or do you want to train your team?

Join industry experts Susan J. Schniepp and Linda Biava for the Training Staff to Detect Data Integrity Issues webinar on Sept. 27 when they present:

  •     High-level data integrity concepts
  •     Recent FDA warning letters citing data integrity
  •     Problem areas for data integrity
  •     Practical tips for training your staff to look for and detect data integrity issues

This 90-minute webinar will cover in detail:

  •     The definition and importance of data integrity
  •     Data integrity code of conduct
  •     Who is responsible for data integrity
  •     Problem areas
  •     Strategies for detecting data integrity issues
  •     QC and laboratory
  •     Computer systems
  •     Manufacturing
  •     Frequency of audits
  •     A culture of quality

Register today to gain an understanding of training staff in detecting data integrity issues.

Meet the Presenters:
Susan J. Schniepp, Fellow, Regulatory Compliance Associates, Inc.
As a pharmaceutical quality assurance thought leader with 35 years of experience, Sue has held leadership roles in the industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC., Searle, Abbott and Hospira. She is a member of the PDA Board of Directors; and has served as the PDA / FDA Joint Regulatory Affairs Conference Chair; conference presenter; and Chair of the PDA’s Regulatory Affairs/Quality Advisory Board.

Linda Biava, RAC, Regulatory Specialist, Regulatory Compliance Associates, Inc.
Linda has over two decades of experience in Regulatory Affairs, Quality remediation, 483/warning letter responses, research and development, and project management. She has provided expertise at Hospira, Organon (formerly Diosynth Inc.), Apotex and the Kansas City Regional Crime Lab.

Who Will Benefit:

  •     Auditors
  •     Clinical project specialists
  •     Clinical research associates
  •     Compliance officers
  •     Consultants/service providers
  •     Data management and statistics personnel
  •     Engineering and design controls teams
  •     Executive management
  •     General/corporate counsel
  •     Investigators    
  •     Managers
  •     Manufacturing directors and supervisors
  •     Personnel new to the industry

Webinar Details:
Training Staff to Detect Data Integrity Issues
Sept. 27, 2016 — 1:30 p.m. – 3:00 p.m. ET
http:// [http://info.fdanews.com/training-staff-to-detect-data-integrity-issues-pr

Tuition:
$287 per site

Easy Ways to Register:
Online:     [http://info.fdanews.com/training-staff-to-detect-data-integrity-issues-pr                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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