If you hold a GMP licence, make ensure you validate your IT system!

by Ryan Watts | Oct 9, 2015 | Blog

Have you been told, often by your finance department that you must prepare for a new computer system? If so please ensure you raise a change control form and carry out a robust risk assessment . All too often the implementation does not run to plan and the results can...

What does a WDA holder have to qualify & validate?

by Ryan Watts | Oct 9, 2015 | Blog, WDA(H), WDA(H)

What does a WDA holder have to qualify & validate ? Their processes, procedures, equipment, packaging, transport, service providers etc. They have to calibrate equipment and  temperature data loggers , balances  etc.   Validation, qualification and...

What should you look for in an outsourcing partner ?

by Ryan Watts | Oct 9, 2015 | Blog, RP

Outsourcing should be considered in small and large organisation where where an expert third party is more effective and economical. The alternative is to  employ and train  in-house experts or retrain existing team members. Quality Expertise can be sought in diverse...

The Duty To Share: effective 1 October 2015

by Ryan Watts | Oct 6, 2015 | Blog

The Health and Social Care (Safety and Equality) Act 2015 introduced a new legal duty for Health and adult Social Care bodies to share information where this could facilitate the care of the individual. There is a requirement for organisations to use a consistent...

Pharmaceutical Care: who is it dependent upon?

by Ryan Watts | Oct 5, 2015 | Blog, Pharmacist

Pharmaceutical Care is a term that has been evolving for a couple of decades now.  In 1990 Hepler and Strand first defined the term as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of...

Devices law suits in the USA

by Ryan Watts | Sep 30, 2015 | Blog

Devices law suits in the USA – Litigation costs are rising. – Provision for litigation should be made in every device manufactures budget especially if they trade in the USA.   A large devices manufacturer of ostomy, continence, urology, and wound and skin care...

Preventing Quality Issues: A Risk-Based Approach to Clinical Trial Monitoring

by Ryan Watts | Sep 28, 2015 | Blog

The traditional Gold Standard method of monitoring clinical trials involved on-site monitoring with 100% Source Data Verification (SDV) where Clinical Research Associates checked every data point of information reported. This may have been doable in the past when...

Are you happy with the results?

by Ryan Watts | Sep 28, 2015 | Blog, NHS

Over the years we have seen the world of pharmacy evolve from that of ‘Dispense and Supply’ to include an ever expanding range of clinical services, (medicines management, local enhanced services such as vascular checks, managing minor ailments and sexual healthcare...

The MHRA Inspection Build-Up

by Ryan Watts | Sep 25, 2015 | Blog, MHRA

Never has the corny old adage “Fail to prepare, prepare to fail” – so glibly used at times – been more wholly appropriate than for the build-up to an MHRA Inspection. It’s a demanding process requiring detailed attention, comprehensive descriptions, staff inclusion...

Not all flu vaccines are equal

by Ryan Watts | Sep 9, 2015 | Blog

For years, flu vaccines were designed to protect against three different flu viruses (trivalent). This included two influenza A viruses and one B virus. Experts had to choose one B virus, even though there are two very different lineages of B viruses that both...