Compliance
April 7, 2020
Top Tips for a Successful Virtual Audit
The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...
Compliance
Life Science Consulting
March 12, 2020
Embracing Risk Management Principles: As Easy as One, Two, Three
In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than...
Compliance
Life Science Consulting
March 7, 2020
Event Recap: MHRA Good Practice Symposia Week
This year, four members of our team attended the MHRA Good Practice symposium week. Part of this week were the GPvP Symposium and the joint MHRA and FDA GCP Symposium. Part of ProPharma Group’s...
Compliance
February 18, 2020
FDA: CGMP Consultant Recommendation
Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...
Compliance
Life Science Consulting
July 29, 2019
Get the Most Out of Your GMP Effectiveness Checks
Get the Most Out of Your GMP Effectiveness Checks: We work in a highly regulated industry. Whether you are associated with the manufacturing of a drug, a biologic, or a device, you understand the...
Compliance
Uncategorized
June 25, 2019
Deviations: Beyond the Basics
Deviations: Beyond the Basics: There are plenty of guidelines and instructions on implementing a deviation system in a pharmaceutical/medical device company. However, there is a big difference...
Compliance
Life Science Consulting
May 30, 2019
FDA’s Top 483 Observations for 2018: A Reflection of Industry’s Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Inspections ending between 10/1/2017 and 9/30/2018, for...
Compliance
March 15, 2019
Assumed Brexit & Batch Control Testing Site In the UK
The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...
Compliance
Life Science Consulting
March 6, 2019
Health Apps and the Requirements Imposed By the Law
If you check Apple’s App Store or Google’s Play Store you will find an overwhelming list of health and fitness apps. This list only gets longer, if you include the number of people who use these...