Skip to content

Add anything here or just remove it...

Home
About Us
Services
Resources
Blog
Contact Us

Resources

Using Risk-Based Thinking To Manage Nonconformances And Deviations

Posted on February 28, 2018March 7, 2018 by QS Compliance

Using Risk-Based Thinking To Manage Nonconformances And Deviations

This entry was posted in Resources and tagged Manage Nonconformances And Deviations, Risk-Based Thinking.

How To Build A Value-Added GMP Supplier Management Program

Use Trending as a Tool for Risk-Based Thinking

Recent Posts

Quality Systems Compliance, LLC Now Certified for ISO 9001:2015 and ISO 13485:2016
21 CFR 11 Electronic Records Electronic Signatures with TOC
21 CFR 210 cGMPs General with TOC
21 CFR 211 cGMPs for Drugs with TOC
21 CFR 801 Labeling with TOC

Mark Durivage Books

Buy Online ►

The Certified Supplier Quality Professional Handbook

The Certified Supplier Quality Professional Handbook

The Certified Reliability Engineer Handbook

The Certified Reliability Engineer Handbook

The Certified Pharmaceutical GMP Professional

The Certified Pharmaceutical GMP Professional

The ASQ CSQP Study Guide

The ASQ CSQP Study Guide

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.
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)

Member, American Association of Tissue Banks (AATB)

Contact Us

3118 Chanson Valley Rd
Lambertville, MI 48144

mark.durivage@qscompliance.com

Name *

Company *

Email *

Comment or Message *

Comment

Site by AKSYS | Managed by 10:31 Marketing

Privacy Policy | Sitelist [admin]

Home
About Us
Services
Resources
Blog
Contact Us

Home » Using Risk-Based Thinking To Manage Nonconformances And Deviations

Copyright 2024 © Quality Systems Compliance, LLC

Home
About Us
Services
Resources
Blog
Contact Us
Newsletter