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Write it Right – Well Written Procedures are Essential for QMS Effectiveness

01-December-2023 :01:00 PM EST Duration : 60 Minutes

Joy L. McElroy,

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more

The webinar will help you to write clear, unambiguous, and flexible SOPs. You will learn techniques for creating easy-to-read and understand SOPs that your employees can consistently follow.

Well-written procedures are a critical ingredient in an effective and efficient quality management system. They are an essential part of meeting the regulatory requirement to “establish and maintain” a suitable and effective quality management system. SOPs are typically one of the first things an investigator asks for during an FDA inspection. Well-written procedures send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and establishes regulatory requirements. More importantly, well-written procedures are the very means to ensure that your personnel can accurately and consistently 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 an 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.

Course Outline:

• 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

• Using process maps to make procedures clear

• Using diagrams and visuals

• Maintaining and controlling SOPs

• Ensuring adequate training to your SOPs

• Best Practices

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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