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Writing Effective SOPs for QMS in the Pharmaceutical and Medical Device Industries
- Lessons Learned from 483s and Warning Letters
- FDA Expectations for SOPs
- Common Problems and Mistakes
- How to Outline and Format your SOPs
- Using Process Maps to Make Procedures Clear
- Use of Visual Aids
- Ensuring Adequate Training to your SOPs
Overview of the webinar
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.More importantly,well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in well documented and justifiable results
This webinar will help you to write clear, concise, and flexible SOPs.You will learn techniques for creating easy to read and clear SOPs your employees can easily follow.Well written SOPs ensure that your employees understand and consistently follow your manufacturing processes.
Who should attend?
- Manufacturing personnel
- Quality Assurance personnel
- Quality Control Personnel
Why should you attend?
“Failure to Follow established SOPs” is the most common observation from regulatory bodies.Translated this means the Standard Operating Procedures (SOPs) put into place were not adequate for personnel to follow as well as record the information needed.Poorly written procedures make it difficult for your employees to understand and consistently follow procedures.Once these SOPs are put into place it is difficult to rectify the problem,putting the work and thoughtfulness up front to make sure your procedures are concise and understandable will save your business trouble when an auditor arrives for an inspection.
Faculty - Mr.Carl Patterson
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.