Aseptic Processing Excellence: Environmental Control under 21 CFR 211
Aseptic Processing Excellence: Environmental Control under 21 CFR 211 In the pharmaceutical manufacturing arena, precision and sterility are non-negotiable. Maintaining…
Aseptic Processing Excellence: Environmental Control under 21 CFR 211 In the pharmaceutical manufacturing arena, precision and sterility are non-negotiable. Maintaining…
Document Control and ISO 13485:2016: Ensuring Compliance and Consistency In the realm of quality management within the medical device industry,…
Starting Strong: cGMP Training as a Key Onboarding Component In the intricate landscape of pharmaceuticals, where precision and quality are…
Streamlining Internal Audits: How Medical Device Quality Managers Can Optimize the Process Welcome to our blog on “Streamlining Internal Audits:…
Overcoming Challenges in Six Sigma Implementation: Strategies for Quality Managers in Manufacturing Implementing Six Sigma within a manufacturing organization can…
Best Practices for Root Cause Analysis in CAPA Investigations Welcome to our blog on “Best Practices for Root Cause Analysis…
Driving Improvement using the ISO 13485 Medical Device Management Review Process Welcome to our blog on “Driving Improvement using the…
From Chaos to Coordination: 6 Tips for Structuring Operations Meetings in Your Manufacturing Startup As someone who has experienced the…
Crafting an Effective Quality Policy for ISO 13485 Compliance in a Medical Device Start-up As a medical device start-up, adhering…
Ensuring Comprehensive Hazard Identification in HACCP: Strategies for Food Manufacturing Facilities Food safety is a critical issue for food manufacturing…
8 Common Mistakes in Setting HACCP Critical Control Points and How to Avoid Them In this blog post, I will…
Mastering the Art of CAPA Verification: Ensuring Effective Corrective Actions in the Medical Device Industry As someone who has managed…
Monitoring Success: Essential CAPA KPIs for Medical Device Companies In the highly regulated field of medical devices, effective corrective and…
HACCP: The Ins and Outs Are you working in the food industry or interested in learning about food safety? If…
Medical Device Internal Audits: The Ins and Outs In this blog post I discuss the ins and outs of internal…
10 Tips for an Effective CAPA Process A Corrective and Preventive Action (CAPA) process is one of the most important…
How are Drug/Device Combination Products Regulated in the USA by the FDA? A key challenge for those contemplating manufacturing drug/device…
6 Problem – Solving Tools to use in Manufacturing Finding effective solutions to complex problems isn’t easy. Using the right…
What are Pharmaceutical Current Good Manufacturing Practices (cGMP)? Compliance to and awareness of pharmaceutical Current Good Manufacturing Practices (cGMP) is…
What is a Combination Product? Remember Jack and Jill, who went up the hill for water? Jack fell down, broke…