Overview:
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:
Learning Objectives:
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
Learning Objectives:
- 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
Speaker
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.Who Should Attend
- Directors
- Managers
- Professionals
- Technical writers and General staff with the responsibility for creating
- Reviewing and approving written standard operating procedures and instructions
