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Audit Examples

API Manufacturing Audits
Domestic and international Pharmaceutical Companies
Reviewed synthetic processes and developed audit plan to TGA and PIC/S requirements for assessing suitability to supply. Assessed and reported on facilities in Italy, Austria, Argentina, India and USA.

  • Produced audit report on quality systems used in API manufacture.
  • Provided risk assessment of strengths and weakness of operation.

Finished Product Manufacturing Audits
Pharmaceutical Company
Developed an audit plan to TGA and PIC/S requirements for assessing capability to manufacture. Assessed and reported on facilities in India.

  • Produced audit report on quality systems used in manufacture.
  • Provided risk assessment of strengths and weakness of operation.

Contract Laboratory Audits
Domestic and International Pharmaceutical Companies
Conducted vendor audits of contract research and testing laboratories to FDA, TGA and PIC/S requirements. Assessed and reported on facilities in UK, India, Canada and USA.

  • Produced audit report on quality systems used in manufacture.
  • Provided risk assessment of strengths and weakness of operation.
ARCS Annual Scientific Congress: Canberra, September 15-16
I will be presenting on "Quality Risk Management in a Laboratory Environment" to this conference.
Go To:
http://arcsconferences.com/#header-can

Advanced Labs 2011: Melbourne September 19-20
I will be running a workshop on Interactive Workshop on "Improving the accuracy of results, turnaround time and reducing costs to enhance customer service delivery".
Go To:
http://www.marcusevans.com/marcusevans-conferences-event-details.asp?EventID=18014&SectorID=27


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Discovery consists of seeing what everybody has seen and thinking what nobody has thought. Albert Szent-Gyorgyi (1893 - 1986) .


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