Making cGMP Documentation Practical
Instructor:
Paula Shadle
Product ID: 700179
Training Level: Basic to Intermediate
- Duration: 60 Min
Many firms struggle with repeated, basic errors in GMP documentation. This webinar discusses why certain types of errors are comonplace, and how to structure training, review, and feedback, to improve performance.Training alone is not effective; people need to understand the ’why’ behind the rules, or they will appear to be arbitrary. Here are strategies you can use, based on concepts of adult learning, risk management, and quality systems.
Areas Covered in the seminar:
- Why is it so difficult to sustain documentation quality?
- The human factor
- Approaches to discussing errors
- Peer feedback as a strong lever
- Untrained people cannot comply well
- Does management buy in?
- Hints and tips
Who Will Benefit:
This seminar will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP. The focus will be on GMP documentation. Employees who will benefit include:
- QA and QC managers and specialists
- All persons required to document data or observations under GLP or GMP
- Executive management seeking to create a pro-quality culture
Paula Shadle, Ph.D., is the founder of Shadle Consulting, a firm that specializes in quality systems and process development for biopharmaceuticals. Dr. Shadle has over 20 years of hands-on and executive experience in biopharmaceutical process development and quality at firms including Chiron, Scios, GSK and Bayer. She has published over 40 publications and is co-inventor on 4 process patents. Dr. Shadle holds a Ph.D. degree in biochemistry from the University of California, and two years’ postdoctoral experience at the Max-Planck-Institute. She is on the boards of the West Coast Chapter, PDA, and the East Bay Chapter, AWIS, and on the editorial board of BioPharm International.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
