No one is in any doubt that efficient and effective internal and supplier audits that meet all the requirements of a medical device company’s external auditors and also add value to the company need to be put in place. But the question is how. This question arises because many medical device companies find that the requirements and guidance documents for medical device quality management systems are couched in language that make internal and supplier audits confusing and ponderous.
These tasks need not be intimidating or tiring for medical device companies anymore.
A two-day seminar (http://bit.ly/1TOvqbg) from the leading provider of professional trainings for the healthcare industry, MentorHealth, will put regulatory professionals at ease with these complexities.
The Director of this course, Betty Lane, who has over 30 years’ experience in Medical Device quality assurance and Regulatory Affairs and is the founder and President of Be Quality Associates, LLC; will help those who will do internal or supplier audits manage an audit process for these or other company audits.
Understanding the importance and complexities of the ISO 13485 and the cGMP
She will provide participants with an easy to understand presentation on the auditing process as well as the requirements they will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP). Lane will familiarize participants with these aspects because auditors need to understand the requirements for the audits they conduct. Also covered are best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements.
At this seminar, the Director will also give an understanding of how participating organizations need to train new auditors for their medical device quality management system or to audit their suppliers.