Field Engineering Blogs | PFMEA
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 designed or redesigned, when control plans for a new or modified process are being developed, when improvement goals are planned, and when analyzing failures. The “P” […]
Regulatory Surveillance Summary | May 2020
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 to a global search for therapies to treat, diagnose, mitigate, or prevent the infection. Before new therapies can be made available […]
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 […]
Regulatory Surveillance Summary | 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 […]
Regulatory Surveillance Summary | February, 2020
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Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act, Draft Guidance, January 2020, Revision 2 This guidance revises the draft guidance Current Good Manufacturing Practice – Interim Guidance […]
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%. […]
Regulatory Surveillance Summary | January, 2020
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 labeling and packaging requirements for vaping products to increase awareness of the health hazards of using vaping products, help prevent the […]
Regulatory Surveillance Summary | December, 2019
By Laurel Hacche, SQA Associate SQA Regulatory Surveillance Summary for Q3-Q4, 2019 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 guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature. […]
Regulatory Surveillance Summary/EU MDR – October 2019
By Boudewijn Jong, SQA Associate, Netherlands Synopsis On 20 May 2020, the new European Union Medical Device Regulation (EU MDR) will go into effect. All Medical Devices manufactured and/or sold in the European Union will be affected by this new regulation. Whether it’s a “simple” syringe or a “complex” insulin pump system with Bluetooth connection […]