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Webinar on How to be Well Prepared to Host a Regulatory Audit

 
  March 18, 2016  
     
 


Compliance Trainings, Online
2016-04-04


Description :

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.

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.

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.

Please Note: This webinar is LIVE-ONLY and will NOT be available in the Recorded format.

Areas Covered in the Session :

Review the items that need to be in place prior to an audit

What to expect during the opening meeting and how to control the audit to your advantage

Practices to implement during the audit and those that need to be avoided

Learn typical audit techniques by investigators and how best to handle them

Learn what your responses should include prior to submitting to the agency for review.

Interactive Q&A Session

Who Will Benefit:

QA/QC Departments

Manufacturing Departments

Engineering Departments

Validation Departments

Regulatory Departments

 

Management Teams

 
 
Organized by: Compliance Trainings
Invited Speakers:

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

 
Deadline for Abstracts: 2016-04-04
 
Registration:

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1667

 

To register this webinar

https://compliancetrainings.com/siteengine/Login.aspx 

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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