July 1, 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
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
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
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.
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
The Best of Year One – an Anniversary Episode.
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
Customized Medicines for Personalized Treatments
You May Also Like
