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.
To minimize this, firms have employed long and extensive SOPs implementing practices that must be
interpreted to require repetition of procedures and protocols that are already approved and accepted.
Extra time is spent for each analysis and this results in greater chances of errors due to over
In this session, the speaker will cover best practices and processes that you can implement to
effectively and efficiently document your daily operations. At the end of this webinar you would have
learned valuable tips to ensure that the quality, completeness and accuracy of you QC laboratory
documentation will positively impact the FDA inspector’s opinion of your operation.
Areas Covered in this Session:
Good Documentation Practices (GDP).
FDA Documentation Requirements.
Calculations – Good, Bad and the Ugly.
Computerization of Calculations.
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:
Walter R. Hahn, is the instructor, lecturer and laboratory supervisor/manager for most of the Pharma
laboratory courses at AAPS. He received his formal training as a chemist at the University of Waterloo,
where he received an Honors Bachelor of Science in Chemistry in 1986. He majored in organic
chemistry and had his name on two publications for his work in synthetic chemistry.
From his first position in Quality Control (1986) as an analyst, to his most recent position with Patheon
as a Raw Material supervisor, Walter has acquired over 20 years experience in the Pharmaceutical
industry, with 12 of those as a QC supervisor in Shelf Life Stability, Finished Products and Raw
Materials. His experience ranges from method development and validation for HPLC, documentation
auditing and GMP trainer, to technical writing, lecturing and laboratory management. He has worked
for several different companies including generic pharmaceutical manufacturers, innovators, contract
laboratories and contract manufacturers.