IVT Network

July 1, 2022

18 Min Read

Journal of Validation Technology

2022

 The EU GMP Annex1 Revision 2022 Implementation

Laboratory Review Process and Its Impact on Compliance

Data Integrity and Integrating Automation

Risk Revolution: ICH Q9 Revision, Is it Enough?

The Quality Control Response to COVID Disruption in Labs

 The New Norm for Life Sciences Talent Evolution

2021

Paper Versus Electronic Records

Ruggedness of Visible Residue Limits for Cleaning Validation

Cognitive Biases in Strategy and Execution

Fuzzy Logic, Risk Management, and Critical Thinking in Pharmaceuticals.

 Integrate Risk into Change Control

Good Distribution Practices and Audit Readiness

The Top Five Data Integrity Issues in GXP Environments

Ask Me Anything – Hot Topics in Quality Risk Management

The Unintended Consequences of USP Compliance

Developing Effective Contamination Control Strategies

 Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk

Revolution

Women in STEM – Overcoming Obstacles and Advancing Careers

Combination Products: Successful Product Development & Regulatory Anticipations & Complexities

Drug Naming and Medication Errors

Quality Management Maturity – A Pilot Program of the FDA

Principles of Parental Solution Validation, a Lifecycle Approach

 Bias, Heuristics & Risk (Pt. 2) on Risk Revolution

Streamlining Change Control – Implementing A Risk-Based Change Management Process

The Evolution of Regulatory Compliance and the Future of Risk-Based Thinking in QMS

 Digitization Of Validation For Effective Virtual Regulatory Inspections

How to Achieve Best in Class Documentation in Life Sciences

2020

Developing a Risk Culture

 Microbiological Risks Associated With Pop-Culture Trends

 One-Voice-of-Quality (1VQ) Solutions Part 2

 Drug Preparation and Administration –Using IV Robotics for Insourcing Ready-to-Administer Sy

Contamination Control and Sterility Assurance for Compounding Facilities

 Robust Knowledge Management Activities in Process Validation to Ensure Intrinsic Compliance

Compounding. Compliance. COVID. The impact of temporary FDA guidance now, and in the future.

Journal of GXP Compliance

2022

 Measuring Cough As Clinical Evidence

Sustainability without Compromise, the story of BioFoam

Critical Thinking, Assessing Risk, and Patient Safety – Setting the Record Straight on CSA

Risk Revolution: Risk Tolerance & Risk Acceptance

Get Smart With Your Data

The Best of Year One – an Anniversary Episode.

2021

IVT Network Awards – 2021

 Computer Systems Validation & Software Assurance – CSA Revolution Commentary –

Disrupting the Risk Paradigm – on Risk Revolution

Revolutionizing Drug Production: A Shift to Continuous Manufacturing

 Excellence and Next Generation Approaches to Quality System Monitoring

A Deeper Dive into Excellence and Next Generation Approaches to Quality System Monitorin

From Dreading the Risk Process, to Living the Risk Life on Risk Revolution

Working in Life Sciences: Talent Recruitment, Retention & Engagement

The Digital Transformation Initiative

COVID’s Long-Term Impact On The Drug Supply Chain

Ensuring Data Integrity in Virtual Environments

Sterilization and Sterility Assurance in Medical Device Packaging

Death by Licorice? Unexpected Toxicity From Drug Products

Bias, Heuristics & Risk (Pt. 1) on Risk Revolution

Eliminating Human Error from Your List of Manufacturing Deviations

 Identification and Management of Critical Data

Another Look At Human Error In the Wake of COVID-19

2020

Customized Medicines for Personalized Treatments

 Life Cycle Approach to Cleaning Validation

Risk Revolution – Let’s Get Some QRM Facts Straight!

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