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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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December 14, 2018 |
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CfPA-The Center for Professional Advancement, Online Live
February 21, 2019 at 11:00 a.m.–12:30 p.m. (ET)
This 90-minute, accredited training is intended to help you better understand and get familiar with best practices for FDA approval process for quality risk management (QRM) applicable for pharmaceutical industry. This webinar is further intended to discuss how risk management plans can be effectively integrated into a quality system (QS) in the pharmaceutical industry. This webinar will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry. In addition, this webinar will help the attendees learn how to develop and implement a systematic and holistic risk management strategy integrated into the quality system.
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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 Danielle DeLucy, MS; Independent Consultant to the Biologics and Pharmaceutical Industries |
Danielle DeLucy, MS, is currently an Independent Consultant to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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Jmorbit@cfpa.com
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