Live -Webinar 2014 - How to Host Regulatory Audits (FDA, EU and Health Canada)

DESCRIPTION
Why you should attend
Getting through a regulatory audit and how to prepare for it, is vital for companies to know and often helps determine the direction of the audit. Preparation is key as well as knowing what inspectors will focus on and actions to avoid. This webinar will give attendees a template to use to help devise a training program to those responsible for meeting inspectors, the audit team, those who will deal with inspectors as well as upper management. Finally, after getting through an audit, observations made still need to be responded to and this webinar will give suggestions as to how best to address them.
Description of the topic
The term “audits” and what it implies, whether performed by regulatory auditors, internal audit teams or third party customers, often invokes both anxiety and questions as to how best to prepare for them. The more a company prepares for an audit, the more likely the results will be to their benefit. Hosting an audit involves the training of all those who may have interaction with the auditors, along with knowing what to expect, how best to address issues raised and above all, how to avoid the mistakes that many companies often make. This webinar will help establish an outline for both the preparation for an audit, along with recommended practices for hosting one. Topics covered will include items to address prior to the audit, during the audit and actions required once the audit has been completed. Attendees will be given the chance to ask questions relating to past experiences with auditors along with questions they may have in anticipation of an upcoming audit. Common audit techniques used by auditors to gather information will be reviewed along with practices to avoid during an audit.
Areas Covered In the Seminar
Topics to be covered in this webinar include the following:
1.) Review the items that need to be in place prior to an audit.
2.) What to expect during the opening meeting and how to control the audit to your advantage.
3.) Practices to implement during the audit and those that need to be avoided.
4.) Learn typical audit techniques by investigators and how best to handle them.
5.) Learn what your responses should include prior to submitting to the agency for review.
Who will benefit
Departments who would benefit from this webinar:
1.) QA/QC personnel
2.) Manufacturing
3.) Engineering
4.) Validation
5.) Regulatory
6.) Management
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance