Writing and Enforcing Effective SOPs (Standard Operating Procedures)
- Speaker:Susanne Manz
- Product Code:GRC-90613
Live Session - How it works
- Username and Password will be sent to you within 24 hours prior to the webinar.
- Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
- Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
- Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
- Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
- Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our email@example.com
Recorded Session - How it works
- Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
- Please click on the link to access the Recording and type in the password provided in the email.
- Presentation and other handouts will be emailed to you in a pdf format.
Training CD - How it works
- Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.
(For more information about our products contact +1- 248-233-2049)
If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at firstname.lastname@example.org.
Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures”. This webinar will help you to write clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating easy to read, clear, and concise SOPs that your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow processes.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. 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 correct outcomes and quality work.
Why Should You Attend
“Inadequate SOP” observations still rank among the most frequently cited 483 and Warning Letter observations. SOPs are one of the first things an auditor/ investigator will review during and inspection. Most importantly, poorly written procedures make it difficult for your employees to understand and consistently follow procedures. This can lead to disastrous consequences including quality problems and even recalls. Poorly written SOPs can and do impact your business.
- Overview of the Regulations
- FDA Expectations
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
This 90-minute webinar will include:
- FDA expectations for SOPs
- Lessons Learned from 483s and warning letters
- Common problems and mistakes
- How to structure your QMS and SOPs
- How to outline and format your SOPs
- Should, Shall, May, Do Not Guidance
- FDA and overall global expectations and requirements for SOP development, implementation and enforcement
- Using process maps to make procedures clear
- Using diagrams and visuals
- Maintaining and controlling SOPs
- Ensuring adequate training to your SOPs
- Best Practices
- Understand the industry standards for procedure writing, including typical components of documents, and using document templates
- Understand the full life cycle of SOPs
- Understand how training is integral to document approval
- Link SOPs to good documentation practices
Who Will Benefit
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to understand Quality System requirements
- Subject Matter Experts who write procedures
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.