This webinar will present:
- What IT Compliance and QA professionals as well as Business Users with responsibilities for system ownership, must do to protect the integrity of their data and systems.
- How to assess possible risks to your data integrity and determine appropriate strategies
- Recommendations for incorporating these processes into your Quality Management System and Computer Validation procedures to reduce risks and ensure stronger controls on data.
Areas Covered in the Session :
- What is Data Integrity as defined by US and EU ealth authorities
- What are the Compliance requirements for Data Integrity
- Why this is critical now
- Risk – What are the possible risks to Data Integrity
- Strategies for risk assessments and determining appropriate mitigations
- Data Risk Assessment processes and Incorporating them into your QMS and CSV
- Interactive Q&A Session
Who Should Attend:
- IT/IS compliance professionals and direct management
- Quality Assurance professionals with responsibilities for IT systems oversight
- IT/IS System and Process Owners
Course Director: GAIL SCHUMACHER
Gail Schumacher’s 20 years of hands-on experience in IT Quality Systems Compliance focuses on Risk Based Computer System Validation for F500 pharmaceutical and medical device companies. Her quality assurance expertise encompasses a deep familiarity with international GxP regulations and the application of risk assessment processes to compliance strategies coupled with a fundamental understanding of IT Systems and the Systems Development Life Cycle.
Gail’s professional practice includes compliance oversight, developing and applying electronic data integrity controls and authoring numerous compliance processes and procedures. She is a change agent, leading cross functional teams in quality process reviews, improvement and implementation. Gail also pre-reviews articles submitted for publication to the Institute of Validation Technologies: Journal of GXP Compliance.
Gail is the founder and owner of Schumacher Consultants, assisting IT Quality Assurance and Compliance professionals in the biotech industry.