Efficient, Effective and Compliant Documentation in the QC Laboratory

This QC laboratory documentation webinar will cover best practices and processes to efficiently document your QC laboratory’s operations so as to positively influence an FDA inspector’s opinion. It will cover documentation requirements to ensure FDA compliance.

Why Should You Attend:

The efficiency and effectiveness of your QC lab is dependent on how well your analysts document their daily operations. Their work is only as good as the records they produce and the documentation will have a direct impact on the inspector’s opinion of your operation. Poor practices and incorrect processes will lead to errors. These are time consuming and expensive. Investigations can tie up supervisors and managers for days or weeks and result in the holding of finished product and delaying the release of raw materials.

Areas Covered in this Session:

• Why Document?
• Good Documentation Practices (GDP).
• FDA Documentation Requirements.
• Errors correction.
• Calculations – Good, Bad and the Ugly.
• Computerization of Calculations.
• Computerized Documentation.
• Integration of existing systems.
• 21 CFR Part 11 Compliance

Who Will Benefit:

This webinar will provide valuable assistance to personnel in FDA regulated industries. Those who will benefit most would be:

• Quality Control
• Quality Assurance
• IT
• Regulatory Affairs