Gary Ritchie

SUMMARY OF QUALIFICATIONS

• 19 years of Pharmaceutical Analytical Laboratory GMP experience in Pharmaceutical Laboratory Management and Manufacturing experience
• 5 years Scientific Fellow and Liaison, United States Pharmacopeia
• Extensive experience writing validation documents on all protocols for URS, DQ IQ/OQ/PQ, (4Q Docs), Risk Assessment protocol and evaluation, and CSV; executed these as well working with 3rd party vendors
• Extensive instrument qualification and instrument, documentation, and computer validation experience
• Extensive experience with Quality Assurance remediation, auditing GMPs, SOPs, 21 CFR Part 11, 211, 820, CAPA, Data Integrity
• Utilized document management, LMS, and lab systems on a regular basis.
• Leader and team player with exceptional management, communication, analytical, and problem-solving skills.
• Production of Educational Material
- Aug 2015 Compliance Online - Elements of Current Good Manufacturing Practices (cGMP) for Complying with the Food Safety Modernization Act (FSMA)
- Sept 2017 Compliance Insight - Food CGMP Risk Management/Internal Audits
- Nov 2017 Center for Professional Advancement - LABORATORY SAFETY: A Comprehensive Environmental, Health and Safety Plan Complying With OSHA, EPA and USP
- Sept 2017 The FDA Group - The Importance of CGMP to the Safety of Compounded Drugs
- Oct 2019 Center for Professional Advancement - Implementing Good Manufacturing Practices for API (Active Pharmaceutical Ingredients): A practical approach with examples and solutions for meeting the ICH Q7 Guide
- November 2020 Informa Markets - Mastering PAT & QbD Through Lifecycle Process Validation

SUMMARY OF QUALIFICATIONS

• 19 years of Pharmaceutical Analytical Laboratory GMP experience in Pharmaceutical Laboratory Management and Manufacturing experience
• 5 years Scientific Fellow and Liaison, United States Pharmacopeia
• Extensive experience writing validation documents on all protocols for URS, DQ IQ/OQ/PQ, (4Q Docs), Risk Assessment protocol and evaluation, and CSV; executed these as well working with 3rd party vendors
• Extensive instrument qualification and instrument, documentation, and computer validation experience
• Extensive experience with Quality Assurance remediation, auditing GMPs, SOPs, 21 CFR Part 11, 211, 820, CAPA, Data Integrity
• Utilized document management, LMS, and lab systems on a regular basis.
• Leader and team player with exceptional management, communication, analytical, and problem-solving skills.
• Production of Educational Material
- Aug 2015 Compliance Online - Elements of Current Good Manufacturing Practices (cGMP) for Complying with the Food Safety Modernization Act (FSMA)
- Sept 2017 Compliance Insight - Food CGMP Risk Management/Internal Audits
- Nov 2017 Center for Professional Advancement - LABORATORY SAFETY: A Comprehensive Environmental, Health and Safety Plan Complying With OSHA, EPA and USP
- Sept 2017 The FDA Group - The Importance of CGMP to the Safety of Compounded Drugs
- Oct 2019 Center for Professional Advancement - Implementing Good Manufacturing Practices for API (Active Pharmaceutical Ingredients): A practical approach with examples and solutions for meeting the ICH Q7 Guide
- November 2020 Informa Markets - Mastering PAT & QbD Through Lifecycle Process Validation

BA, Biology

MS, Biology