Meghan Caldwell
Senior Consultant
About Meghan,
Meghan Caldwell is an experienced Quality consultant with over 10 years of domestic and international GMP experience across pharmaceutical, biotechnology, and medical device environments.
She is a trained auditor at PharmOut, with hands on auditing and compliance experience against the following standards and regulatory framework, including but not limited to:
European Regulations
• Regulation EU 2017 745 on Medical Devices
• Regulation EU 2017 746 on In Vitro Diagnostic Medical Devices
Medical Device Quality and Risk Management
• ISO 13485 Medical Devices Quality Management Systems Requirements for Regulatory Purposes
• Medical Device Single Audit Program
• ISO 14971 Medical Devices Application of Risk Management to Medical Devices
• ISO 22442 Medical Devices Utilizing Animal Tissues and Their Derivatives
Pharmaceutical Manufacturing and Distribution
• PIC S Guide to Good Manufacturing Practice for Medicinal Products
• PIC S Guide to Good Distribution Practice for Medicinal Products
• World Health Organization Good Distribution Practices for Pharmaceutical Products
• Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8
Laboratory and Cosmetics
• ISO IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
• ISO 22716 Cosmetics Good Manufacturing Practices Guidelines on Good Manufacturing Practices
General Quality Management
• ISO 9001 Quality Management Systems Requirements
Meghan brings a pragmatic, risk-based approach to auditing and quality system improvement, supporting organisations before, during, and after regulatory inspections.
Throughout her career, Meghan has delivered complex projects across Quality Management Systems, internal and supplier audits, regulatory inspection readiness and response, CAPA and deviation management, validation lifecycle activities, data integrity, and GxP IT systems.
She has worked extensively with global organisations including Novartis, AstraZeneca, LEO Pharma, Amgen, and Allergan and with a broad range of PharmOut clients across pharmaceutical manufacturing and distribution, medical device manufacturers, complementary medicines, and Software as a Medical Device (SaMD).
