Duration: 90 Minutes


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In the Medical Device industry, companies must “establish and maintain” documents, procedures, and records. This can involve huge numbers of documents. Without a system for control, this can quickly become burdensome and out of control. And when it becomes out of control, mistakes occur. Wrong procedures are followed, documents are incorrect or out of date. And records get lost. This can have disastrous consequences in an FDA inspection. Medical Device Manufacturers must be able to show that they established procedures and the records are the proof they did it. So the records need to be correct, up to date, and easily found/available.

Why You Should Attend :

In an FDA/Regulatory inspection, the manufacturer has the burden of proving that they have established and maintained procedures. In order to do this they need to easily access and present correct records. If you can’t present these records in a timely and efficient manner, how will you convince the regulators that you can produce safe and effective products? Control of records is a basic requirement of a Quality Management System. Can you prove to the FDA and other regulators that you can control all your documents and records? Do you having any land mines lurking in your records?

Areas Covered in the Session : 

  • FDA expectations for Document Controls and Records Management
  • Lessons Learned from 483s and warning letters
  • Common problems and mistakes
  • Strategy for Document Control
  • How to structure your QMS and Document Management System
  • Methods and systems for controlling documents
  • Records retention Best Practices
  • Preparing for an FDA Inspection

Who Should Attend:

  • Quality Systems Teams
  • Document Control Teams
  • Quality and Compliance Teams
  • Internal Auditors
  • Training Departments
  • CAPA Specialists

Course Director: SUSANNE MANZ

Susanne Manz 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. She has a BS in Biomedical Engineering and an MBA from the University of NM. 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.