In celebration of International Women’s Day, BioBuzz caught up with D’Incerti to learn more about the story behind the company, how PQE Group has continued to grow tremendously across the wordl, and its plans for the future.
Stephen Tyrpak is a healthcare executive and commercialization expert with over 14 years’ experience working with medical devices, pharmaceuticals and combination products. He has worked with companies from 5-5,000+ employees and has focused many of his efforts in supporting startup companies. He works for the PQE Group, a global consulting firm with 25 years of success, with more than 2,000 employees located in 32 offices around the globe. He is the Associate VP of Medical Device Operations – US & Canada, and Associate Partner.
Manual visual inspections include everything from filling the product, inspecting it, and acceptance sampling (AQL), which means a certain amount of product is scrutinized at a higher level. If a certain percentage of the total amount being tested shows defects, the entire batch must be addressed. Continuing education following training is important; industry trends are moving so quickly, and adapting so dramatically, it is challenging to keep up with these regulatory guidances, which are revised and updated periodically. The responsibility is on the manufacturer. Just a few examples of FDA’s guidance with respect to manual visual inspections include:
Cybercriminals have engaged in cyberattacks against healthcare organizations for years, and ransomware continues to be relevant despite efforts to combat it. Data breaches remain a common issue, and companies remain vulnerable. Threats are evolving and becoming more sophisticated and effective, with attack vectors increasingly used. Managed service providers, supply chains, and open source software are among those being compromised. And while Governments are increasingly aggressive in fighting back, healthcare organizations have as big a role as ever in defending themselves.