GxPeople will be attending the DIA 2018 Boston next June

GxPeople Directors Nadia Di Meo and Chris Bourffard will be attending the DIA Global Annual Meeting next 24th of June. Sessions will include distinguished speakers and expert panelists from regulatory, industry, patient advocacy, and academia. We’ll be at booth #1553 and we would love … Continues

What Will MDR and IVDR Compliance Mean for You?

New EU regulations came into force in May 2017 which will affect the UK medical device industry. These are the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). These regulations will bring in new standards of compliance … Continues

Why employee engagement is a business essential

Employees are a business’s most valuable resource, so it follows that employee engagement is essential in managing and nurturing this resource. This isn’t simply about looking after your employees’ interests though: a fully engaged workforce can help transform a business … Continues

Can you learn to let go and delegate?

Effective leaders must be able to delegate responsibility. This is a balancing act. You have requirements or tasks you want to complete, with a degree of freedom you will permit to accomplish this. Your staff member needs clarity in instructions … Continues

European Commission Passes Act on GMPs

The European Commission has passed an act detailing how good manufacturing practices (GMPs) apply to medicines that require marketing authorisations. Adoption of the supplementing directive provides member states with principles and guidelines regarding their GMP responsibilities. The directive is designed … Continues

Why do You Fail to Win Your Perfect Candidate?

Business not always a buyer’s market, and this is often true when it comes to pharma and biotech recruitment. Companies are competing for the best recruits, looking for the perfect candidate. There are two distinct parts to this: the recruitment … Continues

How to be an agent of change

In the world of biotech and pharma, no one can afford to stand still. Against a background of demanding legislation dealing with product liability, and increasing demand and competition, it is essential that key individuals are in place to drive … Continues

Can You Lead and Develop a Team?

What does it mean to build a winning team? In pharma and biotech, teams are crucial to success because they are the key to maintaining and improving efficiency and quality. A team must work together to achieve its common goal, … Continues

IVD Quality Management System Implementation Deadline

European lawmakers have started the countdown to the implementation of new medical device and in-vitro diagnostic (IVD) regulations. Manufacturers of all classes of device now have three to five years to implement quality management and post-market surveillance systems. The documents … Continues

International Training for Quality professionals

Quality Requirements for Biotech Products from First-In-Human to Phase III 26. April – 28. April 2017, Frankfurt, Germany organised by Fleming events www.fleming.events The training is useful for: Regulatory framework for Clinical trials of Biotech-IMPs GMP requirements for IMPs, IMPs … Continues

Confused about GMP rules and guidance?

Then this course is for you, full of practical tips and advice for having a well-managed documentation system will explode some of the myths, remove some of the complexity and re-focus upon the GMP rules and guidance and how they … Continues

What does Brexit mean for the QP?

Does the role of QP change? We do not expect any change in the role of QP neither in EU nor in UK. For the time of negotiations (2 years after starting the process) we consider that full delegation of … Continues