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… read more →
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… read more →
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’… read more →
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… read more →
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… read more →
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… read more →
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… read more →
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… read more →
Wins & Challenges It was a crazy summer for the McKay family. After dropping our son off at LAX to attend college overseas, my wife Carrie and I headed to… read more →
SQA Regulatory Surveillance Summary for Q2, 2019 International Council for Harmonization (ICH) Guidance ICH Harmonized Guideline, Optimization of Safety Data Collection, E19, Draft April 2019 This Guideline is intended to… read more →