Writing Effective SOPs for QMS

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.

Why You Should 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.

Areas Covered in the Session :

• 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

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Documentation Departments

Course Director: CARL PATTERSON

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse. To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective. Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD