Good Documentation Practices

Description

Documentation is fundamental to adequately demonstrating that GMP and GCP compliance was employed during product development and commercialization. Documentation needs to meet certain requirements to ensure data validity, product quality and product safety. If these records are poorly prepared or completed, then the clinical data obtained may not be adequately verified or relied upon by the regulatory agency to issue and approval and the manufacture or quality of a product can be negatively impacted. Therefore, it is imperative that Good Documentation Practices be followed throughout the process to ensure that regulatory requirements are met. The standard of documentation within a company can directly impact the level of success in achieving approval of drugs and manufacturing quality products that are safe.

Course Objective

• What are the mandatory document requirements
• Which documents are critical to the regulatory agencies
• How should GDP be employed by the company
• What are the principles of GDP
• Defining the company policy and procedure for each relevant element of GDP
• Managing attachments and printouts to originally created documents

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Course Outline

Topics covered include: 

• Documents to which GDP applies
• Decisions to be made in setting up the company GDP
• Areas to be contained within the company’s GDP policy/training
• How to properly write, manage, and correct documents

Target Audience

This webinar will provide valuable assistance to all personnel in: 
 

• Vice Presidents, Directors, & Managers of GMP & GCP areas
• Employees involved in any area covered by GMP or GCP
• Audit and Compliance Personnel / Risk Managers
• All companies that are required to follow GMP or GCP in their business practices

Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

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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To register/enquire, please contact:

www.compliance.world

Call us at this Toll Free number: +1-866-978-0800