...time during the event. Over the last few years several highly knowledgeable and experienced professionals have joined the Inspectorate, and this year some of them took to the stage for...
...days is very limited and therefore problems with the provision of the TMF could result in the rejection of an application due to the inability to fully evaluate the compliance...
Over the last few years, the inspectorate has tried to raise the profile of the important role of the RP. Deficiencies are now frequently cited against the RP and sometimes...
...chains? The primary requirement is that the supply chain is clearly visible to the certifying QP. The entire supply chain of the active substance and medicinal product up to the...
...gel or ice packs are added to the packaging to maintain appropriate temperatures throughout. The positioning of these packs within the consignment is extremely important and they must not be...
...then predict the probability of the excursion, the impact of the excursion and the likelihood of detection. Probability will be affected by factors such as season, geographical differences and altitude....
...which the delegates were given the opportunity to use the event app and discuss the risks associated in each case and how they could be mitigated. The delegates worked well...
....co.uk email address. The supplier communicates with the criminals believing they are speaking to the wholesaler. When the ordered goods arrive at the wholesaler they are placed in quarantine as...
...Those of you who are regular attendees at these events will have heard me speak on similar themes over the years. The changes brought about by the introduction of the...
...the auditor(s), and have access to the report(s). QPPV oversight – The QPPV must have authority over the pharmacovigilance system, though the MAH remains responsible for the delivery of pharmacovigilance....
