Getting their documentation right is very important for medical device manufacturers

[Adam Fleming]

Documentation is at the heart of medical devices. If a medical device manufacturer cannot convincingly establish documentation of the manufacturing process; the medical device is bound to have regulatory approval hurdles. Every medical device manufacturer has to both establish and maintain all of these: documents, procedures and records, all of which must be under a state of control.

So, what should the documentation establish and prove? Documentation should show that manufacturers followed the prescribed scientific methods and procedures while manufacturing the devices. Only records of all these processes are accepted as proof that all these were followed by the manufacturers. This means that manufacturers need to keep in place several records of varying types, which need to be corrected from time to time with every new step or a revision, and importantly, make these easily available to the designated/authorized personnel.

How do manufacturers get their documentation right?

Given the importance of documentation –the FDA can impose heavy penalties to medical device manufacturers who cannot show the authenticity and integrity of their documentation as well as the recordkeeping methods pertaining to it –it is necessary for manufacturers to be thorough with their methodology. This requires professional training, because this is not something that manufacturers can take chances with.

It is to equip medical device manufacturers with all the elements of documentation and recordkeeping of their medical devices that Compliance4All, a highly popular provider of professional trainings on all areas of regulatory compliance, will organize a webinar. This webinar will be imparted under the expert guidance of Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. More details of this webinar can be had from http://www.compliance4all.com/control/w_product/~product_id=500918LIVE

Ways of ensuring documentation to meet regulatory requirements:

This webinar will be highly useful for personnel in the medical devices industry, for whom the proper method of documentation is critical. Susanne will show what procedures and methods personnel in the many tiers of the medical devices industry need to follow in order to be able to maintain records that are well documented to meet regulatory requirements and how to keep these in the right place for easy access and correction.

She will show how medical device manufacturers can present these records in a timely and neatly organized fashion to the regulatory authorities during inspections, along with ways by which the safety, integrity, authenticity and control of the documentation can be ensured, as well as how to make them accessible and correctable. In other words, this webinar is all about how to meet regulatory requirements pertaining to documentation, a basic requirement of the Quality Management Systems.

Susanne will cover the following topics at this webinar:

o  FDA expectations for Document Controls and Records Management

o  Lessons Learned from 483s and warning letters

o  Common problems and mistakes

o  Strategy for Document Control

o  How to structure your QMS and Document Management System

o  Methods and systems for controlling documents

o  Records retention

o  Best Practices

o  Preparing for an FDA Inspection