2-Day In-Person Workshop (November 4-5, 2015)

Data Integrity Specifics to Bullet Proof Your Audits

Computerized systems have come in for increased scrutiny by auditors. Recent audits have focused on data integrity very aggressively.

This hands-on interactive workshop is designed to extensively cover the entire gamut of Data Integrity beginning with companywide policies and procedures that need to be in place at the corporate level to data integrity specifics such as data integrity attributes and their regulations.  The workshop will address industry issues arising from the lack of clarity on the meaning of data integrity and its implementation. Also addressed will be resolution methods for recent Data Integrity Warning letters. It is designed for novices and advanced users alike and benefits those in senior management and manufacturing personnel who use computer systems for laboratories, clinical trials, biopharmaceutical manufacturing, and medical device industries as well as for IT system vendors engaged in the development of systems and software for the biopharmaceutical industry.

Through numerous case studies, participants will review audit and inspection approaches, case studies, FDA 483s and warning letters so as to enable them to speak the same “language of Data Integrity” as those of the regulators and thereby significantly reduce risk of audit failures.

Take back to your work, samples of Data Integrity related SOPs such as corporate wide Data Integrity policy, data integrity risk management, data integrity validation etc.

Some Data Integrity training highlights....
  • What is Data integrity
  • Why is Data Integrity important
  • What the regulators are after during Data Integrity audits 
  • How do you know that you have a Data Integrity problem in your company
  • The elements of a Corporate Data Integrity program
  • Roles and responsibilities of different groups in ensuring data integrity
  • The design specifics for life cycle design of Data Integrity 
  • Validating Data Integrity
Who should attend:
  • Pharmaceutical industry / Medical device industry / Healthcare industry personnel
  • Developers of software for use in Life Sciences industry
  • Validation service providers, IT service providers
  • Manufacturing personnel and Manufacturing Automation system vendors and system integrators
  • Regulatory Affairs group, Quality Unit

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: info@fdamap.com