Advancing CAPA in Life Sciences for Better Quality and Compliance
CAPA in life sciences is one of the most critical systems for ensuring product quality, patient safety, and regulatory compliance. It is also one of the most common sources of audit findings across pharmaceutical, biologics, and medical device organizations. Despite mature quality systems and strict regulatory oversight, many companies continue to face recurring deviations, delayed […]
SQA Regulatory Surveillance Summary | 3Q/4Q 2025
Staying informed on the latest pharmaceutical compliance updates is essential for navigating an increasingly complex global regulatory landscape. From evolving GMP requirements and regulatory guidance to enforcement actions and emerging risks, these updates directly impact how organizations manage quality, ensure compliance, and protect patient safety. This summary highlights key developments across major health authorities and […]
The Importance of Requirement Consumption by the Supplier for New Product Launches
Bringing a new device to market is one of the most critical milestones for any manufacturer. It’s a driver of growth, innovation, and improved outcomes. In the highly regulated medical device industry, it’s a process with zero margin for error. From concept design to commercial release, every step must comply with strict FDA, ISO 13485, […]
Why PPAP Is Critical for Medical Device Manufacturing
Implementing PPAP effectively doesn’t just reduce regulatory risk—it can save time and money across the medical device industry supply chain.
SQA President & CEO Michael Guymon Shares Insights on Supply Chain Quality
In a recent episode of Bridge the Gap, hosted by Dale Zwizinski and Adam Jay from Revenue Reimagined, Michael Guymon, President & CEO of SQA Services and former leader at SpaceX and Rocket Lab, shares his insights on building suppy chain systems that don’t crack under pressure—and what go-to-market teams can learn from high-stakes industries. […]
SQA Regulatory Surveillance Summary for 3Q/4Q 2024
Review key 2024 regulatory shifts still influencing 2025—covering pharma, medical devices, AI, cosmetics, and global compliance strategies.
SQA Regulatory Surveillance Summary | Monthly Update 2023 – January
SQA Regulatory Surveillance Summary for January 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner China: National Medical Products Administration (NMPA) NMPA Announcement on putting into use the electronic certificates of Documentation for Export of Active Pharmaceutical Ingredients (APIs) to the European Union (EU) and Certificate of a Pharmaceutical Product (No. 95, 2022), 08 November […]
SQA Regulatory Surveillance Summary | July 2020
Coronavirus Regulatory Guidance and Emergency Measures – July 2020 This regulatory surveillance summary reviews key global regulatory developments from July 2020, including coronavirus guidance, emergency regulatory measures, and compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates European Medicines Agenda (EMA) Parenteral Drug Association (PDA) News – EMA: Final Assessment Report on Nitrosamines, 22 […]
Medical Device Regulations & Regulatory Surveillance Summary – June 2020
This regulatory surveillance summary highlights key global regulatory developments from June 2020, including updates to Medical Device Regulations, guidance documents, and compliance expectations. By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, June 2020 US FDA is publishing a […]
COVID-19 & Regulatory Surveillance Updates – May 2020
This regulatory surveillance summary reviews key global regulatory developments from May 2020, including covid-19 guidance, emergency regulatory measures, and compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations and Guidances Health Canada Announces Another Step to Accelerate Access to Health Products for COVID-19, 27 May 2020 The COVID-19 pandemic has led […]