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What is SALSA Certification? A Practical Guide for Food and Drink Manufacturers
Food Safety Management

What is SALSA Certification? A Practical Guide for Food and Drink Manufacturers

Over the past few months, I’ve attended several industry events and had conversations with food manufacturers about the challenges they’re…

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From Quantity to Quality: What China’s Five-Year Plan Can Teach Us About Manufacturing Excellence
Manufacturing | Medical Device

From Quantity to Quality: What China’s Five-Year Plan Can Teach Us About Manufacturing Excellence

From Quantity to Quality: What China’s Five-Year Plan Can Teach Us About Manufacturing Excellence Reflections on quality, manufacturing capability and…

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FDA QMSR: Why Your Management Review Is No Longer Protected (And What FDA Will Expect)
Medical Device

FDA QMSR: Why Your Management Review Is No Longer Protected (And What FDA Will Expect)

FDA QMSR: Why Your Management Review Is No Longer Protected (And What FDA Will Expect) In our previous guide, FDA…

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FDA QMSR 101: What Every Medical Device Professional Needs to Know
Medical Device

FDA QMSR 101: What Every Medical Device Professional Needs to Know

FDA QMSR 101: What Every Medical Device Professional Needs to Know The FDA’s Quality Management System Regulation (QMSR) became enforceable…

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Manufacturing Training Galway | Featured in the Galway Advertiser
News

Manufacturing Training Galway | Featured in the Galway Advertiser

Manufacturing Training Galway | Featured in the Galway Advertiser We were delighted to be featured in the Digital Business &…

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Top 7 Training Priorities for MedTech SMEs Entering Manufacturing Scale-Up
Medical Device

Top 7 Training Priorities for MedTech SMEs Entering Manufacturing Scale-Up

Top 7 Training Priorities for MedTech SMEs Entering Manufacturing Scale-Up For small and medium-sized enterprises (SMEs) in the medical technology…

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Computer System Validation (CSV) 101: A Beginner’s Guide for FDA-Regulated Medical Device Companies
Medical Device

Computer System Validation (CSV) 101: A Beginner’s Guide for FDA-Regulated Medical Device Companies

Computer System Validation (CSV) 101: A Beginner’s Guide for FDA-Regulated Medical Device Companies If you work in a medical device…

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Mastering Complaint Management: A Guide to 21 CFR 820 and ISO 13485:2016 Compliance
Medical Device

Mastering Complaint Management: A Guide to 21 CFR 820 and ISO 13485:2016 Compliance

Mastering Complaint Management: A Guide to 21 CFR 820 and ISO 13485:2016 Compliance In the complex and highly regulated world…

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Navigating 21 CFR 820: A Guide to Quality System Regulations for Medical Device Manufacturers
Medical Device | Regulation

Navigating 21 CFR 820: A Guide to Quality System Regulations for Medical Device Manufacturers

Navigating 21 CFR 820: A Guide to Quality System Regulations for Medical Device Manufacturers Navigating the complexities of 21 CFR…

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Identifying and Addressing Skills Gaps in Manufacturing: A Guide for Employers
Manufacturing

Identifying and Addressing Skills Gaps in Manufacturing: A Guide for Employers

Identifying and Addressing Skills Gaps in Manufacturing: A Guide for Employers In today’s rapidly evolving manufacturing landscape, businesses face an…

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The Learning Reservoir Heads to Web Summit 2024 in Lisbon!
News

The Learning Reservoir Heads to Web Summit 2024 in Lisbon!

The Learning Reservoir Heads to Web Summit 2024 in Lisbon! We’re thrilled to share that The Learning Reservoir will be…

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Navigating CAPA Challenges: Common Pitfalls and How to Avoid Them
CAPA | Medical Device | Problem Solving | Root cause analysis

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…

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

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…

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Building a Resilient Foundation: Brainstorming Skills for Startup Manufacturing Teams
Manufacturing

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…

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Spotting Weak Links: The Importance of Gap Assessments in Medical Device Quality Management
FDA | GMP | Regulation

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…

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Aseptic Processing Excellence: Environmental Control under 21 CFR 211
FDA | GMP | Pharmaceutical cGMP

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…

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Document Control and ISO 13485:2016: Ensuring Compliance and Consistency
Combination Product | Medical Device

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,…

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Starting Strong: cGMP Training as a Key Onboarding Component
FDA | GMP | Regulation

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…

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

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:…

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Overcoming Challenges in Six Sigma Implementation: Strategies for Quality Managers in Manufacturing
Manufacturing | Problem Solving | Root cause analysis

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…

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Best Practices for Root Cause Analysis in CAPA Investigations
CAPA | Medical Device | Problem Solving | Root cause analysis

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…

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Driving Improvement using the ISO 13485 Medical Device Management Review Process
Medical Device | Regulation

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…

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

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…

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

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…

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

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…

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8 Common Mistakes in Setting HACCP Critical Control Points and How to Avoid Them
Food Safety Management | HACCP

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…

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

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…

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Monitoring Success: Essential CAPA KPIs for Medical Device Companies
CAPA | Medical Device

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…

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HACCP: The Ins and Outs
Food Safety Management | HACCP

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…

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Medical Device Internal Audits: The Ins and Outs
Medical Device

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…

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