Overview:
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.
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
Why
should one attend this webinar?
“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.
Who
will benefit by this webinar?
- 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 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.
Enrollment Options
Tags: Writing, Effective, SOPs, Medical Device, Pharmaceutical, 2021, November, Carl, Patterson, Webinar