Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
Instructor:
Carl Patterson
Product ID: 706162
Training Level: Intermediate
- Duration: 60 Min
Why Should You Attend:
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.
“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 Webinar:
- 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 Will Benefit:
- Pharma & drug manufacturing personnel
- Quality Control personnel
- Quality Assurance personnel
- Personnel involved with medical device manufacturing
- Personnel involved with training and development
- Document Control Personnel
Carl Patterson
QA Team Lead, Bachem
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.
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.
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