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What does the medical device/biotechnology auditor look for and why?

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.

Apart from going by these guidelines; the auditor also uses her intuition and observation gained from personal experiences to ensure that the facility she has visited is putting in place the right mechanisms to ensure what a state of control looks like. Given that a medical device audit can happen at just about any time; it is imperative for an organization in the medical device industry to be prepared for an audit any time, all the time.

What are the points that the manufacturer has to bear in mind to ensure compliance, so that the medical device audit goes on smoothly without events? What processes and methods should it follow to pass a medical device audit? These are critical questions that the manufacturer needs to have answers for.

Thorough learning on how to think like the auditor

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will equip participants with the knowledge needed to clear a medical device audit. José Mora, a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, will be the speaker at this very important webinar. Over the more than 30 years that José worked in the medical device industry, he specialized in manufacturing, process development, tooling, and Quality Systems; he introduced process performance, problem solving, and Quality System methodologies.

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His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

You can gain the benefit of his experience by registering for this webinar at http://bit.ly/2laaQ7G

The mental checklist

The important learning of this webinar is that José will provide insight into the auditor’s way of thinking. He will explain the kinds of clues an auditor might use in determining what areas to focus on. Rather that offer a heads-up on the regulations and standards relating to medical device audits; José will give knowledge of the general mental checklist.

Adhering to this checklist, an intuitive one created more out of the expert’s knowledge and experience rather than one gleaned from textbooks, will go a long way in determining how well an audit goes. He will also explain what kind of culture and environment a medical device organization’s management has to inculcate and encourage, so that the medical device auditor gains a better than normal perception of the organization.

An eye on the visual clues

An experienced auditor who knows her job does not need to look too far or deep to discover anomalies. The checklist she has in her mind is enough for her to match the facility’s requirements with those in it. At this webinar, José will bring his years of experience in helping participants understand how to frame a mental checklist of their own, so that they map it with that of the auditor.

He will emphasize the importance of housekeeping, proper maintenance, orderliness, and following safety rules. He will also highlight the importance of objects that serve as visual indicators in the facility, and will show how to follow them. Generally, in most medical device facilities, utility rooms and custodial closets are dumping places for several items. An experienced auditor is aware that what a medical facility hides in these places are a greater indicator of the facility’s orderliness than what are kept in the clean and presentable areas. The expert at this webinar will show how to maintain cleanliness in these areas and keep them presentable for the auditor.

José will cover these areas at this webinar:

  • What the auditor is looking for and why
  • The first five minutes
  • Touring the plant and manufacturing area
  • Entering and touring the warehouse
  • Entering and touring a cleanroom
  • Entering and touring lab areas
  • Reviewing documents
  • Reviewing the quality system
  • Summary

This course offers immense benefit to those in charge of handling auditors. These include Managers, Supervisors, Directors, and Vice-Presidents.

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