All sessions are now FULL for Globiox’s office hours at the Texas Health CoLabs on August 15th and 16th, 2019. Check back in September for extended hours. Don’t forget – space is extremely limited and sessions are reserved quickly!
Posts by globiox
Globiox’s Office Hours at The University of Texas Health CoLab
Globiox is excited to announce office hours at The University of Texas Health CoLab to meet with aspiring life science companies for 1 hour consultations regarding Quality Management Systems, GxP Audits, Regulatory Strategy, Operations Support, Information Technology, Computer System Validation, Equipment Qualification, Facilities Qualification, and Clinical Services. ***Reservations are made through the dellmed.utexas.edu website (provided
Latest Updates on Regulatory
Written by: Andrey Grishin, MD, Globiox Consultant With the recognition by the US Food and Drug Administration (FDA) of last country-member Slovakia just a few weeks ago, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective
Clinical Evaluation Reports (CER) –
Written by: Daniel Miranda, Globiox Consultant Clinical evaluation is a critical, ongoing task that must be performed by medical device manufacturers who market products in the European Union and seek to obtain or maintain a CE mark. This task is completed via creation of a clinical evaluation report (CER). A CER must be created prior
Almost There: Safety and Performance Pathway Option for 510(k) Submissions
Written by: Daniel Miranda, Globiox Consultant On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for 510(k) submissions. This pathway gives another option for medical devices that have technological differences but that are still as safe and effective as a legally marketed predicate device. Typically, in these situations, the
Equipment validation is not process validation
Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ,
FDA plans major overhaul, looks to be more specialized
5 months ago the FDA announced that in response to “unparalleled challenges” posed by advances in science, globalization and product complexity, the agency would need to realign its programs. With very little detail it was revealed that it would be led by a Program Alignment Group (PAG) consisting of all executive-level members of each of
We do what we do for a reason
There was a talk given at a recent conference by a man named Rick Roberts, who has been a victim of both drug shortages and counterfeit drugs. Mr. Roberts grew up in small town in the US. Due to health problems, he had an inhaler from age one. Because of this, he had many trips
CGMP now includes supply chain management
Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and addresses several areas, including the drug supply chain. The FDA regulates products from more than 150 countries. There are over 130,000 importers into the US, with over 300,000 foreign facilities providing these goods. FDA regulated shipments at more
The FDA’s “dos” and “don’ts” for responding to a 483
DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to observations that are noted as being repeated from previous inspections. If you have not remediated a previous observation, it may be that you did not understand what the FDA meant. Ask! If