The FDA and other world health authorities require industries to submit Standard Operating Procedures (SOPs). However, at present, there exists no guide on how to develop or manage SOP creation, or regarding the SOP quality system. Because of that, SOPs are often written in a way that makes compliance really difficult. In this webinar, our speaker will discuss SOPs, and take you through the process of writing effective documents. You will also learn how to write, organize and maintain SOPs. The speaker will also provide guides on how to train personnel to ensure compliance, in an easy way.
You will learn and understand about written procedures, and why they are beneficial. Our speaker will also cover important subjects such as FDA expectations for written documents and regulatory requirements, implementation of a training program for creating and reviewing documents, development of a system for controlling, archiving and disposing of written proposals, and development of an effective review and approval process, which complies with regulatory requirements.
Learn how to meet their expectations and fulfill their requirements, so your documents are approved quickly, and there are no complications or problems. For preparing the documents, you need to know how to format SOPs, what elements to include in them, and how to write effective and efficient documents. You also need to know the roles and responsibilities of SOP authors and reviewers, and how to define roles in SOPs.
Areas Covered in the Session :
- SOPs and their relation to the regulations
- 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
- 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
Who Should Attend:
- Quality Managers
- Quality Engineers
- Production Teams
- Research and Development Teams
- Compliance Teams
- Documentation Teams
- Regulatory Affairs Teams
- Small Business Owners
Course Director: DANIELLE DELUCY
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.