Skip to content
  • Add anything here or just remove it...
Quality Systems ComplianceQuality Systems Compliance
  • Home
  • About Us
  • Services
  • Resources
  • Blog
  • Contact Us
How To Establish Sample Sizes For Process Validation Using C=0 Sampling Plans

How To Establish Sample Sizes For Process Validation Using C=0 Sampling Plans [...]

How To Establish Sample Sizes For Process Validation Using Statistical Tolerance Intervals

How To Establish Sample Sizes For Process Validation Using Statistical Tolerance Intervals [...]

How To Establish Sample Sizes For Process Validation Using LTPD Sampling…

How To Establish Sample Sizes For Process Validation Using LTPD Sampling… [...]

Integrating Risk Management In The Quality Management System

Integrating Risk Management In The Quality Management System — A Primer [...]

Using Risk-Based Thinking To Manage Suppliers

Using Risk-Based Thinking To Manage Suppliers [...]

Use Trending as a Tool for Risk-Based Thinking

Use Trending as a Tool for Risk-Based Thinking [...]

Using Risk-Based Thinking To Manage Nonconformances And Deviations

Using Risk-Based Thinking To Manage Nonconformances And Deviations [...]

How To Build A Value-Added GMP Supplier Management Program

How To Build A Value-Added GMP Supplier Management Program [...]

Techniques to Identify Outlier Data for Process Validation, Control, Monitoring
Identifying Outliers In Process Data Using Visual And Analytical Techniques

Identifying outlier data points using visual and analytical techniques is especially important for proper process [...]

Using Risk Based Thinking To Manage Nonconformances And Deviations By Mark Durivage ASQ Fellow
Using Risk-Based Thinking To Manage Nonconformances And Deviations

The CAPA process has eight distinct steps. Each step has specific requirements that should be [...]

  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
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.
Read Full Article ►

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

(419) 265-2862

Site by AKSYS | Managed by 10:31 Marketing
Privacy Policy | Sitelist [admin]
  • Home
  • About Us
  • Services
  • Resources
  • Blog
  • Contact Us
Home » Blog

Copyright 2025 © Quality Systems Compliance, LLC
  • Home
  • About Us
  • Services
  • Resources
  • Blog
  • Contact Us
  • WooCommerce not Found
  • Newsletter