This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.
Upon completion of this course the learner should:
Why Should You Attend:
Data integrity is fundamental in a Pharmaceutical Quality System which ensures that medicines are of the required quality. This requires an understanding the expectations for data integrity from a CGMP perspective. Reviewing FDA guidance documents and citations in FDA warning letters will facilitate this understanding. Providing practical steps which can be taken will help your organization reduce the likelihood of receiving a Warning Letter due to Data Integrity issues.Upon completion of this course the learner should:
- Understand what Data Integrity is, and why it is so important.
- Be familiar with regulatory expectations for laboratory notebooks and computer systems.
- Be familiar with issues that resulted in warning letters from the FDA.
- Understand some practical steps that can be taken to facilitate good documentation and reduce the likelihood of receiving a warning letter for data integrity issues.
Areas Covered in the Webinar:
What is meant by ‘Data Integrity’?- Data integrity expectations from the FDA guidance
- Discussion on computer systems, notebooks and spreadsheets
- FDA warning letters citing data integrity issues
- Practical steps you can take to avoid being cited
- Questions and discussion
Who Will Benefit:
- Quality Control Personnel
- R&D Scientists
- Laboratory Supervisors and Managers
- Quality Assurance Personnel
- Chemists/Managers
- Regulatory Affairs Personnel
Course Provider
Gregory Martin,
