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Webinar on Basic Requirements for IQ, OQ and PQ Quality Protocols

 
  June 02, 2016  
     
 


Compliance Trainings, Online
2016-06-03


This webinar will highlight the importance of establishing specifications, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.

Any equipment, system or utility used for GMP impacted products or services must demonstrate they are suitable for their intended use and operate according to their design. To prove these requirements, the protocols developed for both installation and operational verification (and others) are expected to be in place and approved prior to use. This webinar, designed for those just starting to be responsible for qualification activities, will help establish an outline of the basic components for these two protocols. In addition, common deficiencies cited by regulators will also be reviewed in order to help attendees avoid similar issues when their protocols are audited.

Please Note: This webinar will NOT be available in the Recorded format

Areas Covered in the Session :

Review common protocol types and the typical information included in each.

Discuss common deficiencies cited with each type.

Review how best to summarize results and the handling of deviations encountered

Discuss questions that attendees may have regarding their current practices.

Who Will Benefit:

Quality Assurance Teams

Quality Control Teams

Manufacturing Teams

Production Teams

Regulatory Teams

Laboratory Personnel

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: 2016-06-03
 
Registration:

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1668

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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