Governed by FDA and world health authorities, (SOPs) are industry regulatory requirements. When used in combination with planned training and regular performance feedback, SOPs facilitate an effective and motivated workforce. It is obvious that most people want to do a good job. A manager is successful when he/she can channelize the efforts of workers towards positive business development. If the SOPs are written well enough, they tend to improve communication, provide direction and improve consistency at work. Developing the SOP process is a good way for managers/technical advisers and workers to cooperate for everyone’s benefit.
Objectives of the Presentation:
You will learn how you can develop an effective review and approval process which will be compliant with regulatory requirements. Also, know how to implement a training program for document review and creation. In addition, learn how to format SOPs and provide a system for control, archival and disposal of written procedures.
Why should you Attend:
Currently, no guidance is available on how to manage or develop the SOP creation or quality system. This leads to SOPs written so complicated and erroneous that compliance becomes difficult and sometimes impossible. Many cases have led to production of subpar documents which have come to light during a regulatory inspection.
Attend the webinar to know why written procedures and beneficial and understand the FDA expectations for regulatory requirements and written documents.
- 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
ASA Training and Quality Consulting LLC
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.
Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.
- Technical writers and General staff with the responsibility for creating, reviewing and approving written standard operating procedures and instructions