Remote GxP Consultancy

Expanding our virtual consultancy services, bringing additional pharma and biotech expertise directly to you, when you need it and exactly how you need it.

We know that when you need an answer to a technical question, an assessment of risk or an evaluation of the options available to resolve a difficult situation, you demand:

• Rapid access to a credible and seasoned expert in the field
• Support that helps develop a proportionate, timely and justifiable response to the challenge ahead

For this reason, over the last few years, we have:

• Utilised video conferencing to support businesses around the world, at short notice and often free of charge
• Implemented the highly acclaimed NSF Pharma app that includes all the new cGMP expectations; our free webinars, white papers and videos; and an ‘ask the expert’ feature
• Expanded our eLearning offerings
• Expanded our portal of free-to-view videos and webinars, spanning the full range of compliance, science and leadership subjects (Visit www.nsf.org/info/pblibrary)

But what’s new?

In these uncertain times, we know rapid access to the right solution is imperative, and we wanted to share four expanding services with you.

We want to help you find and maintain ‘true north’ in the tough journey that you are embarking on.

Helping You to Find and Maintain True North

NORTH: Live 1:1 Consultancy

Our management team are available to you right now at short notice for a video conference where we can discuss the challenges ahead, the best available options, how to maintain the supply chain or how to cope with restricted resources or travel. Our team of experts are here to listen, synthesise the issue and offer practical guidance and rapid support. We are offering this first session free of charge until July 31, helping you to focus on the priorities needed. We’ve noticed how a ‘problem well-defined and shared is a problem half solved’ and we can help you to make the right first steps in the journey ahead.

EAST: Live 1:1 Coaching

We have noticed how many organisations are having to repurpose their teams, changing the role and function of many team members to suit the new paradigm ahead. We are all expecting to change, to pivot in our roles and to learn some new skills for rapid deployment in the workplace. For some, this will feel like a gift that enthuses and engages, yet for others this can feel very daunting and stressful. We have been coaching new pharmaceutical leaders for decades and we know what is needed. We have developed a range of virtual, highly interactive training (alongside eLearning), but we know individuals under pressure need 1:1 guidance too. Contact us and we can discuss how we can help you to transition yourself or your team into new roles and responsibilities, helping you to hit the ground running.

SOUTH: Remote Support to Your Pharma Quality System

We appreciate that your resources and network have changed and maintaining the cGMP expectations defined in your pharmaceutical quality system is a huge challenge. We know that a backlog of incident investigations, OOS reports, change controls, qualification and validation studies, GMP audits, technical agreements and supplier/internal risk assessments is almost inevitable. How can you keep this backlog from spiralling out of control? How can you minimise the negative impact to the KPIs that you use to measure the performance of the quality system? We are currently working globally to support firms remotely, by providing expert oversight to a variety of quality systems, ensuring a timely, accurate and valuable review is completed to best effect. Expertise is in short supply just now and we invite you to access our team for additional horsepower and insight in these difficult times.

WEST: Remote Policy and SOP Review

Our VP of Health Sciences, Lynne Byers, is leading a comprehensive remote project just now; to assist a multinational company in its plans to upgrade GxP related policies and SOPs. Her team are providing authorship or technical review of new draft policies and procedures, and then providing 1:1 coaching of the upgrades to the local team. This approach is building local capability and making improvements, despite the restrictions and challenges we are facing. The input maintains the momentum of the project and helps to keep a predictable glidepath to the place the firm needs to be in the future. Our expert input is proving invaluable, not just to improve GMP but also to ensure clarity, brevity and accuracy in the processes the SOPs define, seeking to improve focus and minimise human error or intrinsic causes of deviation.

These services have always been here at NSF, but we have expanded them in response to listening to you, especially in these unprecedented times.

Please don’t hesitate to contact us at pharmamail@nsf.org.