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....Serving the Pharmaceutical Industry

QUALITY ASSURANCE AUDITING ACTIVITIES. . .

Dr. Cox has served clients in numerous tasks related to quality assurance auditing functions within the pharmaceutical, food, and medical device industries and has specialized in assisting these companies to attain or retain compliance rapidly and efficiently. His specific experiences are listed.

GMP - Pharmaceutical Manufacturing Variances Review (21CFR211)

  • Over 280 On-Site Audit Days - Ongoing
  • Manufacturing Variances Review and Certification
  • Laboratory Variances Review and Certification
  • Reviewed and Certified more than 700 investigations (9/03)

    GMP - Batch Certification - Tablets/Aerosols Manufacturing (21CFR211)

  • Over 220 On-Site Audit Days
  • Manufacturing Records Review
  • Laboratory & Raw Material Records
  • Certified drug batches valued in excess of $75 million (4/03)

    GMP - Drugs/Food Manufacturing Site Audits

  • Over 50 On-Site Audit Days
  • Laboratory Procedures Revision & Review
  • Manufacturing Records Review
  • Audit Reports/Analysis

    GCP - Clinical Study Site Audits

  • Over 14 On-Site Audit Days
  • Complete Clinical Records Review
  • Source Documents Verification
  • Audit Reports/Analysis

    Integrity Audits - Abbreviated New Drug Applications

  • Over 85 On-Site Audit Days
  • Complete Review of ANDA Submission Documents
  • R&D/Production/Raw Material Records Assessment

    GMP - Medical Device Facility Audits (21CFR820)

  • Over 44 On-Site (33 days) and Off-Site Audit days
  • Device Manufacturing Records
  • Raw Material, Training, & other pertinent Records
  • Generation and Review of GMP Manuals & SOPs
  • Responsible for FDA certifications granted to 16 companies

    GMP - Batch Certification - Tablets Manufacturing (21CFR211)

  • Over 206 On-Site Audit Days
  • Spanish-English Manufacturing Records Review
  • Raw Material Records
  • Certified drug batches valued at $20 million

    GMP - Records and Facilities Review

  • QA, QC, & Manufacturing Records & SOP's
  • Computerized Analytical Records/Lab Notebooks

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    DP COX ASSOCIATES · 437 Lock Street Phillipsburg, NJ 08865 · Bus.(908)859-2631 · FAX (908)859-2875

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