Effective Standard Operating Procedure (SOPs) Development
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Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.
Why you should Attend:
Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection.
In this webinar you will learn how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is reproducible and easy to follow.
Areas Covered in the Session:
- 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
Who Will Benefit:
- Formatting SOPs
- Elements to include other than the procedure
- How to write effective but efficient documents
- Roles and responsibilities of authors and reviewers of SOPs
- How to define roles in SOPs for supervisors and operators
- Technical writers and General staff with the responsibility for creating
- Reviewing and approving written standard operating procedures and instructions
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 17 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.