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Navigating CAPA Challenges: Common Pitfalls and How to Avoid Them

Navigating CAPA Challenges: Common Pitfalls and How to Avoid Them

Navigating CAPA Challenges: Common Pitfalls and How to Avoid Them Corrective and Preventive Actions (CAPA) are fundamental components of quality…

Building Excellence: Step-by-Step Guide to Conducting Training Needs Analysis for Medical Device Startups

Building Excellence: Step-by-Step Guide to Conducting Training Needs Analysis for Medical Device Startups

Building Excellence: Step-by-Step Guide to Conducting Training Needs Analysis for Medical Device Startups In the dynamic landscape of medical device…

Building a Resilient Foundation: Brainstorming Skills for Startup Manufacturing Teams

Building a Resilient Foundation: Brainstorming Skills for Startup Manufacturing Teams

Building a Resilient Foundation: Brainstorming Skills for Startup Manufacturing Teams In the fast-paced and resource-constrained landscape of startup manufacturing, the…

Spotting Weak Links: The Importance of Gap Assessments in Medical Device Quality Management

Spotting Weak Links: The Importance of Gap Assessments in Medical Device Quality Management

Spotting Weak Links: The Importance of Gap Assessments in Medical Device Quality Management In the dynamic landscape of medical device…

Aseptic Processing Excellence: Environmental Control under 21 CFR 211

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…

Document Control and ISO 13485:2016: Ensuring Compliance and Consistency

Document Control and ISO 13485:2016: Ensuring Compliance and Consistency

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

Starting Strong: cGMP Training as a Key Onboarding Component

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

Streamlining Internal Audits: How Medical Device Quality Managers Can Optimize the Process

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

Overcoming Challenges in Six Sigma Implementation: Strategies for Quality Managers in Manufacturing

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

Best Practices for Root Cause Analysis in CAPA Investigations

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

Driving Improvement using the ISO 13485 Medical Device Management Review Process

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 a Manufacturing Startup

From Chaos to Coordination: 6 Tips for Structuring Operations Meetings in a Manufacturing Startup

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

Crafting an Effective Quality Policy for ISO 13485 Compliance in a Medical Device Start-up

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

Ensuring Comprehensive Hazard Identification in HACCP: Strategies for Food Manufacturing Facilities

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

8 Common Mistakes in Setting HACCP Critical Control Points and How to Avoid Them

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

Mastering the Art of CAPA Verification: Ensuring Effective Corrective Actions in the Medical Device Industry

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

Monitoring Success: Essential CAPA KPIs for Medical Device Companies

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

HACCP: The Ins and Outs

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

Medical Device Internal Audits: The Ins and Outs

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

10 Tips for an Effective CAPA Process

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?

How are Drug/Device Combination Products Regulated in the USA by the FDA?

How are Drug/Device Combination Products Regulated in the USA by the FDA? A key challenge for those contemplating manufacturing drug/device…

From Problems to Solutions: 7 Essential Problem-Solving Techniques for Manufacturing Teams

From Problems to Solutions: 7 Essential Problem-Solving Techniques for Manufacturing Teams

From Problems to Solutions: 7 Essential Problem-Solving Techniques for Manufacturing Teams From production line hiccups to supply chain disruptions, the…

What are Pharmaceutical Current Good Manufacturing Practices (cGMP)?

What are Pharmaceutical Current Good Manufacturing Practices (cGMP)?

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?

What is a Combination Product?

What is a Combination Product? Remember Jack and Jill, who went up the hill for water? Jack fell down, broke…