PMcG Consulting
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Support for Quality Systems


Understanding quality matters related to daily operations, scientific advances, and regulatory standards is essential

in today's pharmaceutical industry.


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PMcG Consulting offers Quality Management support to:


  • Laboratories
  • Manufacturing facilities
  • Distribution organizations
  • Companies seeking enhanced technical expertise during regulatory audits


Support is available in the following areas:


  • Root Cause Analysis Investigations (Quality incidents)
  • Implementation of Corrective and Preventive Actions
  • Monitoring and Trending of Quality System Incidents for Ongoing Improvement
  • Self-Inspection Programs
  • Technical support for regulatory audits
  • Structured Training Initiatives
  • Development of Master Validation Plans
  • Consideration of Data Integrity Principles
  • Maintenance of Quality Management Systems
  • Oversight of Quality System Elements
  • Adherence to Good Manufacturing Practice Regulations
  • Supplier Qualification

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    Laboratory setting with various glassware containing colorful liquids, pills, and chemicals on a reflective surface.

     

     Contracted Pauline to assess analytical methods validation, and to subsequently create a 'gap' report - and then to work at 'fixing' the gap. Pauline was excellent in her attention to detail, and her thorough knowledge of what was needd. She also worked on several projects after that one - always with the same high standards and commitment to provide value to the client. I heartily endorse her work. 

     

     

    Eric Penrose

    President Corporate Quality at Septodont



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    Phone

    1-905-257-6738

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    Email

    pauline@pmcgconsulting.com


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