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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. Description 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 documentation. 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: 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 Engineering Scientists Documentation Instructor Profile: 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.

QC laboratory documentation to ensure FDA compliance effectively and efficiently