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Full Day Virtual Webinar : Process Validation for Medical Devices - FDA Inspectors are Checking – Are You Prepared?

 
  May 10, 2010  
     
 


Complianceonline, Online Web Event
2010-05-12


A detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. Information to include in the protocols and reports, Statistical Process Control, Design of Experiments, usage of attribute sampling plans, discussion on GHTF document on process validation.

 

Learning Objectives:

Sign up your entire team and get a clear understanding of the requirements and methods for process validation, including:

  • Understanding what “a high degree of assurance” means in statistical terms.
  • The three step approach employing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Developing protocols and reports for IQ, OQ, and PQ.
  • What information to include in the protocols and reports.
  • How to use the link the IQ Protocol to OSHA requirements to enhance your total regulatory compliance.
  • The basics of Statistical Process Control (SPC) to help monitor the validated process.
  • The role of Design of Experiments (DOE) to help define acceptable process parameters and develop challenge points.
  • Using attribute sampling plans in process verification.
  • The FDA Guidance document on process validation and the current status from the CDRH view.
  • The Global Harmonization Task Force (GHTF) document on process validation.

 

 
 
Organized by: ComplianceOnline
Invited Speakers:

Daniel O'Leary, has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, reliability, and operations management. Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence. Ombu helps companies achieve efficient and effective processes and regulatory compliance.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001 & ISO 14001), and project management. Dan is a member of the American Mathematical Society, American Statistical Association, Society of Industrial and Applied Mathematicians, Institute for Supply Management, Project Management Institute, APICS, and is a Senior Member of the American Society for Quality and has held leadership positions in ASQ sections. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

 
Deadline for Abstracts: Call contact
 
Registration: Online Registration
E-mail: admin@complianceonline.com
 
   
 
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