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Statistical Procedures Needed for Compliance with the Guidance on Process Validation


Wednesday, November 14, 2012
Online Training
Wilmington, United States

http://bit.ly/TsXaNB

Event Type: Conference

procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft. 

This guidance document contains several statements that make it clear that statistical procedures will be expected. Some of these procedures are of an advanced nature and companies need to be prepared to meet these requirements.

Areas Covered in the Session:

  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">In general what topics does the new draft guidance cover?
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">What are the specific statements?
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">What are these statistical procedures, and how are we expected to apply them?
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">If we lack statistical expertise, what can we do to ensure compliance?

Who Will Benefit:

  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Personnel who will need to plan and execute process validation studies.
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Supervisors who will need to review process validation reports and execute studies. 
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Quality assurance and control personnel.
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Managers responsible for quality operations.
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Auditors and others who will need to periodically review or check studies.

 

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