IPA

Can medical devices be used to rob banks?

Or: how do the new FDA regulations regarding cyber security of medical device protect the public? Author: Ofer Yifrach-Stav In the bustling bank, customers lined up patiently, absorbed in their financial transactions, and the tellers diligently carried out their duties behind the counters. Philip M. Masterson, the bank manager, walked across the polished marble floor, […]

Regulatory Trends in Computer Systems Validation and Data Integrity: The Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the Covid 19 Pandemic

Author: Mr. Gaurav Walia, M.S., Senior Global Director and Principle CSV/CSA and DI SME/Consultant, PQE Group The Covid 19 pandemic created immense challenges for the Pharmaceutical, Biopharmaceutical and Medical Device Industries, and for companies researching, developing, and manufacturing Rx products around the world. From 2020 to 2022, all processes were dramatically impacted by the pandemic […]

Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts

Authors: Kim Huynh-Ba and Laure L. LarkinFor Corresponding, contact kim.huynhba@pharmalytik.com ABSTRACT Scientists and regulators have warned the industry about the importance of creating a Disaster Plan for over three decades. We have experienced industry disruptive weather events like Hurricanes Katrina and Maria, geological events including Fukushima, industrial accidents like Deep Water Horizon and Chernobyl, and […]

GMP Requirements in the EU

The contents of this article will discuss GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder compliance overview. EU requirements differ from those anywhere else in the world.

FDA Inspection Readiness – is your company ready?

All Pharmaceutical Quality Systems must operate to a high standard on a daily basis without the requirement for any major preparation activities in advance of an inspection if they are to be considered inspection ready.

Brexit Checklist for the Pharma Industry

A disorderly Brexit is moving from a possibility to a probability. While governments pass last minute legislation over the month of March, it is encouraging to be part of a responsible industry that treats the threat to patients very seriously and has, according to our government officials, prepared very well for the changes ahead.