by Jackie (née Heneghan) Peck | Jul 24, 2017 | Blog
The MHRA have been issuing majors to pharmaceutical wholesalers for several years if they do not have a backup procedure and there is no evidence of it being tested. Loss of data may result in a critical finding if it cannot be produced during an inspection. Why do...
by Jackie (née Heneghan) Peck | Jul 24, 2017 | Blog
Is the software embedded in your medical equipment vulnerable to a cyberattack? Equipment running older software is much more vulnerable to cyberattack. Older software may be embedded in medical devices and may require regular updates. Find out if it is possible?...
by Jackie (née Heneghan) Peck | Jun 21, 2017 | Blog, Export Training, Training
Seven useful terms: “IATA” “The International Air Transport Association “this body regulates air travel worldwide. IATA are responsible for security and safety of air travel and the regulation of air transport of dangerous goods. “CEIV “Centre of Excellence for...
by Jackie (née Heneghan) Peck | Jun 21, 2017 | Blog, Consultancy
Quality Management Systems (QMS) for Wholesalers can be built by a consultant alone, but the best QMS is one which has input from the Company, the staff who carry out the activities and the managers who are responsible for the business and specific processes within...
by Jackie (née Heneghan) Peck | May 23, 2017 | Blog, Brexit, Good Distribution Practice - GDP, WDA(H)
The UK triggered Article 50 of the Treaty on European Union on 29th of March 2017 and as a result all primary and secondary law ceases to apply to the UK from 30th of March 2019. Companies who hold centrally authorised “MA s” must proactively review their MA terms,...
by Jackie (née Heneghan) Peck | May 15, 2017 | Blog
I read with interest that the largest suppliers of PGDs has folded with immediate effect. They have trained over 2000 people, and issued certificates of PGD service provision. This is begging the question why? Have they fallen fowl of CQC? Have they gone into...