Meredith Crabtree
GMP Quality Consultant & Validation Specialist
About
Meredith Crabtree has over 30 years' experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting and specializes in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.
Credentials
- 30+ Years GMP Experience
- IQ/OQ/PQ Specialist
- Consent Decree Support
- Multi-Industry QA Expert
Related EduCraft Resources
Topics Taught on EduCraft
- Complaint Handling and Investigation: Linking CAPA, MDR Reporting, Trend Evaluation, and Recall ConsiderationsMonday, October 26, 2026
- Cleaning Validation Lifecycle Control: Monitoring Drift, Method Sensitivity, and Revalidation DecisionsThursday, October 29, 2026
- Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally
- Aseptic Processing and Contamination Control Under EU GMP Annex 1: Practical Applications for Modern Sterile Operations
- IQ, OQ & PQ in 2026: What Now Counts as Sufficient Validation Evidence
- OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for Manufacturers
- AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend
- OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026
- Quality Metrics & KPIs: How to Measure What the FDA Actually Cares About
- FDA Registration, Listing & Facility Licensing — Common Pitfalls and Best Practices
- IQ, OQ & PQ in 2026: What Now Counts as Sufficient Validation EvidenceThursday, June 25, 2026
- AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to DefendThursday, June 25, 2026
- FDA Warning Letters & Computerized Systems: From Validation Failures to Inspection-Ready CSV/CSAMonday, October 5, 2026
- Software Validation Observations in FDA Warning Letters and Consent Decrees: Patterns, Root Causes, and Remediation ExpectationsWednesday, October 14, 2026
- Risk Management for AI/ML Medical Devices: Applying ISO 14971 and ISO/TS 24971-2:2026Tuesday, October 6, 2026
- Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes OperationallyFriday, August 21, 2026
- AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to DefendThursday, September 10, 2026
- OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for ManufacturersFriday, September 4, 2026
- Aseptic Processing and Contamination Control Under EU GMP Annex 1: Practical Applications for Modern Sterile OperationsMonday, August 3, 2026
- OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026Tuesday, September 1, 2026