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21 CFR 7 Enforcement Policy with TOC

Posted on March 20, 2022April 20, 2022 by QS Compliance

21 CFR 7 Enforcement Policy with TOC

This entry was posted in Downloads & Documents and tagged Enforcement Policy.

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Mark Durivage Books

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The Certified Supplier Quality Professional Handbook

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The Certified Reliability Engineer Handbook

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The Certified Pharmaceutical GMP Professional

The ASQ CSQP Study Guide

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Practical Process Validation

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Practical Engineering Process, and Reliability Statistics

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Practical Design of Experiments

Practical Design of Experiments

Practical Attribute and Variable Measurement Systems Analysis MSA

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Medical Device Single Audit Program (MDSAP)
Statistical Process Control
Design of Experiments (DOE)
Introduction to Quality Systems
Sampling Plans (Variable and Attribute)
Introduction to Metrology
Introduction to Process Validation
Documentation & Audit Preparation
Mechanical Blueprint Reading
Welding Blueprint Reading
FDA Inspection Readiness
Good Documentation Practices (GDP)
Good Manufacturing Practices (GMP)
ASQ Certification Preparation
Corrective and Preventive Actions (CAPA)
Quality System Requirements (QSR Overview)
Introduction to Measurement System Analysis (MSA)
Animal Tissue

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Quality Systems Compliance specializes in the following areas:

Internal Audits
Supplier Audits
Gap Assessments
FDA 483 and Warning Letter responses
FDA 483 and Warning Letter remediation
Risk-based auditing systems (internal & supplier)
External regulatory and certification audit support
Document and Procedure Writing & Review
Process Optimization
Management Review
Regulatory Affairs support
Mock FDA Inspections
Design of Experiments (DOE)
Measurement System Analysis (MSA)
Test Method Validations (TMV)
Corrective and Preventive Actions (CAPA)
Process Validations
Process Monitoring
Quality Metrics
Procedures and Work Instructions
Sampling Plans (Variable and Attribute)
Training
Medical Device Single Audit Program (MDSAP) Audits
Animal Tissue

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Recognized as a Top Ten Medical Device Consulting Company in 2019 by MedTech Outlook.
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Top 10 Medical Device Consulting Companies 2019

Member, Society of Reliability Engineers (SRE)

Member, Regulatory Affairs Professionals Society (RAPS)

Member, Association for the Advancement of Medical Instrumentation (AAMI)

Member, American Association of Tissue Banks (AATB)

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