PFMEA for Field Engineering: Process Failure Mode and Effects Analysis
PFMEA is a structured risk management tool that helps organizations identify and mitigate process failures, including those identified through field engineering feedback and real-world performance data. By Gilberto Jimenez, SQA Senior Engineering Director PFMEA is a methodology for analyzing any sort of process. Some reasons to utilize this tool include when a process is being […]
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 […]
SQA News | Spring 2020
Interview with Mike McKay Well, what a crazy twist 2020 has taken since our last newsletter! Following my trip to Europe at the end of February, the world began to turn upside down with the immense outbreak of COVID-19 moving throughout Europe and into the United States. Luckily, with our amazing team at SQA, we […]
US FDA & Regulatory Surveillance Updates – April 2020
By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Biological Product Deviation Reporting for Blood and Plasma Establishments, March 2020 The US FDA has provided blood or plasma establishments with revised recommendations related to biological product deviation (BPD) reporting. The guidance document is intended to assist blood […]
Regulatory Surveillance Summary | March 2020
By Laurel Hacche and Debra Cortner, SQA Associates Personal Care Products Council Personal Care Products Council (PCPC) COVID-19 Summary, 20 March 2020 In an effort to comply with health authorities’ recommendations for social distancing and in an abundance of caution, PCPC has closed their offices, and staff is working remotely to maintain business continuity and […]
Warning Letter Updates: Regulatory Surveillance Summary – Feb 2020
This regulatory surveillance summary reviews key global regulatory developments from February 2020, including warning letter issuances, FDA enforcement actions, and compliance updates. By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of […]
SQA News | Fall/Winter 2019
Wins & Challenges Welcome to a new decade, everyone! We had a huge ending to our 2019 year, gathering momentum into the fourth quarter to make it the top quarter of the year. I’m proud to say that we also managed to diversify our client base so that no single client represents more than 8.5%. […]
Health Canada Regulatory Updates: Regulatory Surveillance Summary – January 2020
This regulatory surveillance summary reviews key global developments from January 2020, including Health Canada guidance, regulatory updates, and international compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations/Guidances Regulation of Vaping Products in Canada, December 2019 On 19 December 2019, Health Canada announced the final “Vaping Products Labelling and Packaging Regulations,” creating new […]
Drug Recall Updates: Regulatory Surveillance Summary – December 2019
This regulatory surveillance summary reviews key global regulatory developments from December 2019, including drug recall actions, FDA warnings, and compliance updates. By Laurel Hacche, SQA Associate United States Food and Drug Administration (US FDA) Guidances (Devices and Drugs) Device Guidance: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations, October 2019 This […]
EU MDR Regulatory Updates October 2019: Regulatory Surveillance Summary
EU MDR Regulatory Updates October 2019 – Regulatory Surveillance Summary This regulatory surveillance summary outlines key EU MDR regulatory updates from October 2019, highlighting guidance, implementation considerations, and regulatory developments affecting medical device manufacturers. By Boudewijn Jong, SQA Associate, Netherlands Synopsis On 20 May 2020, the new European Union Medical Device Regulation (EU MDR) will […]