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medical device regulation quick reference checklist
EU Medical Device Regulation (EU MDR) 2017-745 Quick Reference

Medical Device Regulation (MDR) 2017-745 Quick Reference Regulation (EU) 2017/745 Medical Device (EU MDR) of [...]

19
Mar
in-vitro diagnostic regulation quick reference
EU In-Vitro Diagnostic Regulation (EU IVDR) 2017-746 Quick Reference

In-Vitro Diagnostic Regulation (IVDR) 2017-746 Quick Reference Regulation (EU) 2017/746 In Vitro Diagnostic Medical Devices [...]

19
Mar
Risk process for determining the appropriate AQL
c=0 Sampling Plan Table

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

30
Aug
Understanding DOE’s Foundational Elements
January 27, 2020

Design Of Experiments 101: Understanding DOE’s Foundational Elements By Mark Durivage, Quality Systems Compliance LLC [...]

Is Your Personnel Hygiene Plan Up To Date
Is Your Personnel Hygiene Plan Up To Date?

By Mark Durivage, Quality Systems Compliance LLC Every organization that is regulated by the FDA [...]

27
Dec
How To Prepare For An FDA Inspection
How To Prepare For An FDA Inspection

How To Prepare For An FDA Inspection By Mark Durivage, Quality Systems Compliance LLC Every [...]

30
Jul
A Military Tool For Pharma Vulnerability Assessment
A Military Tool For Pharma Vulnerability Assessment — The CARVER + Shock Technique

By Mark Durivage, Quality Systems Compliance LLC Following the terror attacks of Sept. 11, 2001, [...]

13
Jun
FDA Proposes Program To Establish Voluntary Pharma Quality Standards
FDA Proposes Program To Establish Voluntary Pharma Quality Standards

By Mark Durivage, Quality Systems Compliance LLC The FDA’s Center for Drug Evaluation and Research [...]

14
May

REcent Documents & Downloads

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21 CFR 11 Electronic Records Electronic Signatures with TOC
March 9, 2023

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21 CFR 210 cGMPs General with TOC
March 20, 2022

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21 CFR 211 cGMPs for Drugs with TOC
March 20, 2022

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21 CFR 801 Labeling with TOC
March 20, 2022

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21 CFR 803 Medical Device Reporting with TOC
March 20, 2022

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21 CFR 806 Medical Devices Reports of Corrections and Removals with TOC
March 20, 2022

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21 CFR 807 Establishment Registration and Device Listing with TOC
March 20, 2022

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21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC
March 20, 2022

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21 CFR 810 Medical Device Recall Authority with TOC
March 20, 2022

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21 CFR 820 Proposed QMSR with TOC
March 20, 2022

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21 CFR 820 QSR and Preamble with TOC
March 20, 2022

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21 CFR 820 Quality System Regulation with TOC
March 20, 2022

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21 CFR 821 Medical Device Tracking Requirements with TOC
March 20, 2022

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21 CFR 830 Unique Device Identification with TOC
March 20, 2022

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21 CFR 1271 cGMPs for HCTPs with TOC
March 20, 2022

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21 CFR 4 Regulation of Combination Products with TOC
March 20, 2022

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21 CFR 7 Enforcement Policy with TOC
March 20, 2022

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TECHNICAL ARTICLES

EU Medical Device Regulation (EU MDR) 2017-745 Quick Reference
February 2021

EU In-Vitro Diagnostic Regulation (EU IVDR) 2017-746 Quick Reference
February 2021

Preparing for an ISO Audit
January 2021

Design Of Experiments 101 Understanding DOE’s Foundational Elements
Pharmaceutical Online
December 2019

Process Characterization The Foundation For Validation
Pharmaceutical Online
November 2019

FDA’s Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained
Med Device Online
November 2019

FDA Updates Several 510(k) Guidance Documents
Med Device Online
October 2019

An Introduction To Sampling Plans
Pharmaceutical Online
October 2019

What Happens To ISO 13485 When Annex L Is Adopted
Med Device Online
September 2019

Is Your Personnel Hygiene Plan Up To Date?
Pharmaceutical Online
August 2019

How To Prepare For An FDA Inspection
Pharmaceutical Online
July 2019

A Military Tool For Pharma Vulnerability Assessment — The CARVER + Shock Technique
Pharmaceutical Online
May 2019

FDA Proposes Program To Establish Voluntary Pharma Quality Standards
Pharmaceutical Online
April 2019

What Should You Do After An FDA Inspection?
Pharmaceutical Online
March 2019

Integrating Risk Management Into Your QMS An Essential Toolkit
Pharmaceutical Online
June 2018

A Better Way To Document QMS Procedures & Work Instructions In Life Sciences Manufacturing
Pharmaceutical Online
May 2018

How To Build A Value-Added GMP Supplier Management Program
Pharmaceutical Online
February 2018

Using Risk-Based Thinking To Manage Nonconformances And Deviations
Pharmaceutical Online
November 2017

Use Trending as a Tool for Risk-Based Thinking
Pharmaceutical Online
September 2017

Using Risk-Based Thinking To Manage Suppliers
Pharmaceutical Online
June 2017

An Introduction to qFMEA – ​A Tool For QMS Risk Management
Pharmaceutical Online
May 2017

Integrating Risk Management In The Quality Management System
Pharmaceutical Online
April 2017

How To Establish The Number Of Runs Required For Process Validation
Life Science Connect
January 2017

How To Establish Sample Sizes For Process Validation When Destructive Or Expensive Testing is Required
Life Science Connect
January 2017

How To Establish Sample Sizes For Process Validation Using LTPD Sampling…
Life Science Connect
December 2016

How To Establish Sample Sizes For Process Validation Using Statistical T…
Life Science Connect
October 2016

How To Establish Sample Sizes For Process Validation Using C=0 Sampling Plans
Pharmaceutical Online
September 2016

How To Use Reliability-Based Life Testing Sampling For Process Validation
Life Science Connect
August 2016

How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem
Life Science Connect
July 2016

Risk-Based Approaches To Establishing Sample Sizes For Process Validation 
Life Science Connect
June 2016

TECHNICAL DOWNLOADS

STATISTICAL TABLES

Normal Distribution Z Tables

Distribution of the Chi-Square

Percentage Points of the t-Distribution

PRESENTATIONS

*available upon request