Key Insights from the 2025 PDA Regulatory Conference
Highlights from the PDA Regulatory Conference: AI in compliance, predictive quality, training evolution, and FDA inspection readiness strategies.
SQA Regulatory Surveillance Summary for Q1 2025
Stay informed with SQA’s Q1 2025 Regulatory Surveillance Summary, featuring key updates from FDA, EMA, WHO, ANVISA, NMPA, and other global health authorities.
Supplier Equipment Qualification and Its Impact on Packaging Specifications
In the life sciences industry, packaging is far more than a box or a seal. It is a validated system—a safeguard designed to maintain sterility, preserve product integrity, and meet the rigorous requirements of ISO 11607 and FDA regulations. Yet one of the most overlooked risks in this space comes from a seemingly routine event: […]
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 systems that don’t crack under pressure—and what go-to-market teams can learn from high-stakes industries. 1. Defining Quality in […]
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 for May and June 2024
SQA Regulatory Surveillance Summary for May and June 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA will use Analysis of Equivalent Foreign Authorities for Inspection and GMP Certification Process, 03 May 2024 In the Official Gazette of the Union, ANVISA has published the Normative Instruction (IN) 292/2024, which […]
SQA Regulatory Surveillance Summary for March and April 2024
SQA Regulatory Surveillance Summary for March and April 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Brazil: Agência Nacional de Vigilância Sanitária (Anvisa) Anvisa Extends the Validity Period of the Certificate of Good Manufacturing Practices to Four Years, 22 March 2024 The validity of the Certificate of Good Manufacturing Practices (CBPF or cGMP) of […]
SQA Regulatory Surveillance Summary for January and February 2024
SQA Regulatory Surveillance Summary for January and February 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Publishes New Edition of the Biovigilance Manual, 17 January 2024 In Brazil, biovigilance covers a set of monitoring and control actions, ranging from donation to the clinical evolution of a recipient […]