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Friday, May 08, 2020
1:00 PM - 2:30 PM
1:00 PM - 2:30 PM See all dates and Times
https://bit.ly/3a4bPxn
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OVERVIEW Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs (standard operating procedures) that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well-written SOPs ensure consistent process output and quality results.
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 FDA audit. 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.
AREAS COVERED
• FDA expectations for SOPs
• Lessons learned from 483s and warning letters
• Common problems and mistakes
• How to structure your QMS and SOPs
LEARNING OBJECTIVES
• Overview of the regulations
• FDA expectations
• Lessons learned and common mistakes
• SOP best practices
• Preparing for an FDA audit
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
Use Promo Code MDTD20 and get flat 20% discount on all purchases.
To Register (or) for more details please click on this below link:
https://bit.ly/2UWfhFF
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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 FDA audit. 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.
AREAS COVERED
• FDA expectations for SOPs
• Lessons learned from 483s and warning letters
• Common problems and mistakes
• How to structure your QMS and SOPs
LEARNING OBJECTIVES
• Overview of the regulations
• FDA expectations
• Lessons learned and common mistakes
• SOP best practices
• Preparing for an FDA audit
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
Use Promo Code MDTD20 and get flat 20% discount on all purchases.
To Register (or) for more details please click on this below link:
https://bit.ly/2UWfhFF
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882