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CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
September 7, 2016 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend?
This training has been designed to benefit professionals in the FDA regulated industries including pharmaceutical, medical device, biotechnology, cosmetic and food. It will be especially valuable to those Directors, Managers, Professionals, Technical writers and General staff charged with the responsibility for creating, reviewing and approving written standard operating procedures and instructions. Course Description
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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 owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. 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, consent decrees and those wishing to improve compliance 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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This 90-minute accredited training will cover such topics as:
• Why written procedures are beneficial
• FDA expectations for written documents and Regulatory Requirements
• Developing an effective review and approval process compliant with regulatory requirements
• How to implement a training program for document creation and review
• A system for the control, archival, and disposal of written procedures
Can't Make this LIVE Webinar?
Simply select the On Demand option when registering and we will send you the link to view the recorded version.
This course will be available On Demand: September 8, 2016