Founded in 2021 by Mike Villa. In a world pushed sideways by the global COVID-19 pandemic, he saw the opportunity to use his experience in the pharmaceutical and cosmetic manufacturing arena to assist businesses with their challenges in an increasingly complex environment.
With experience in Pharmaceuticals (21 CFR 211), Compound Pharmacies (503b), and OTC/Personal Care manufacturing, he can provide the benefit of his experience to your Quality System development/Improvement, Quality Assurance, Quality Control, and Quality Compliance challenges.
About Us....
Mike holds current certifications as a Certified Quality Auditor (CQA) and Certified Pharmaceutical GMP Professional (CPGP) from the American Society of Quality.
Services
Learn more about what we can do for you...
Training
Paladin AC can provide your organization with the training your organization needs on the following topics:
- Introduction to Quality System Management
- Introduction to Microbiology
- Introduction to Process Validation
- FDA Inspection Readiness
- Good Manufacturing Practices (GMP)
- Good Documentation Practices (GDP)
- GEMBA
- Corrective and Preventative Actions (CAPA)
- Root Cause Investigations
Specializations
We specialize in the following:
- Internal Audits
- Supplier Audits
- FDA 483 and Warning Letter remediation
- Document and Procedure Writing and Review
- Management Review
- Key Performance Indicator (KPI) development and measurement
- Mock FDA Inspections
- Process Monitoring
- Quality Metrics
- Document Development (Procedures, Work Instructions, Training)
Auditing to Standards
Paladin AC can help your organization with audits to assess your company against the following standards:
ISO 9001 Quality Management Systems
ISO 14001 – Environmental management systems
ISO 22716:2009, Cosmetics: Good Manufacturing Practices
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 801 Labeling
21 CFR Part 820 Quality System Regulation
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