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)
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
Experience
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)
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
