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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

The Certified Supplier Quality Professional Handbook

The Certified Reliability Engineer Handbook

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The Certified Pharmaceutical GMP Professional

The Certified Pharmaceutical GMP Professional

The ASQ CSQP Study Guide

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The ASQ CSSBB Study Guide

The ASQ CSSBB Study Guide

Practical Process Validation

Practical Process Validation

Practical Engineering Process, and Reliability Statistics

Practical Engineering Process, and Reliability Statistics

Practical Design of Experiments

Practical Design of Experiments

Practical Attribute and Variable Measurement Systems Analysis MSA

Practical Attribute and Variable Measurement Systems Analysis MSA
Training

Quality Systems Compliance provides
CUSTOMIZED COURSES to meet your training requirements, available in the following topics:

  • 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
Specializations

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
Awards & Memberships

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)
Contact Us
3118 Chanson Valley Rd
Lambertville, MI 48144
mark.durivage@qscompliance.com

(419) 265-2862

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