This post will provide a guide to getting the most out of your visits and hosting reciprocal visits of fellow QP trainees. Visits will form a significant part of your QP training. For most of us
our working environment will not cover all the dosage forms and
relevant aspects within the study guide. Even those trainees working for large multinational companies there will likely be areas of the study guide that they wont be able to cover within their respective company. This is especially important for those trainees within specialist areas such as PET radiopharmaceuticals, ATMP & medicinal gases.
Tips for arranging visits:
1. Gap analysis
A gap analysis of your current CV or draft application form against the study guide will identify areas that you are not familiar with. Listing these will form the basis of the ideal visits that you'd like to arrange to plug these gaps. Your sponsor should be heavily involved in this process to ensure that all areas are considered.
Coming from a NHS background I identified a number of areas I'd want to visit. These included, water systems, high speed packaging lines, API manufacturer (biological & chemical), high speed sterile filling lines as well as RA & PV departments.
2. Networking
Once you have identified the main areas that you'd like to cover you'll need a list of appropriate contacts of people who may be able to arrange a visit. This is where your sponsor should be able to help. They should have a great network of contacts that you can utilise. By now you may now have built up your own network from training courses, conferences, symposiums etc, so now is the time to dig out those business cards and start emailing.
3. Arranging a visit
One of the most important aspects of visits is knowing what you want to get out of them before you go. Your aims should be discussed with your sponsor and your host in order to determine how long you will need to meet these. Once you set a date for the visit begin working on an itinerary with your host. Sometimes your host will provide an itinerary but you will need to ensure everything that you want to cover is included - if it isn't then amend the itinerary. If necessary be specific and focus on one main topic for your visit especially if your time on site is limited. During one visit I focused solely on the facility's water system and nothing else as I only had a half day on site.
It is always worth asking for a scenario session with the host which covers typical examples (real life if possible) that occur within their processes.
4. Preparing for the visit
Leading up to your visit it is important to spend some time preparing for the things you'll likely be witnessing. try to get as much background knowledge on the subject area before you go. Your sponsor should be able to provide you with a good overview of the subject but there are some good alternative sources available to you. Before heading to visit a high speed packaging line I searched you tube for the packaging line manufacturer (Ulhmann) and found a number of useful videos which gave me an idea of what to expect.
5. During the Visit
Don't turn up empty handed - always bring some biscuits, sweets etc for the host and their team. The other important thing to bring with you is a memory stick/usb drive. Most of the trainee QPs will have numerous electronic resources which they may be willing to share. It helps if you bring some of your own to trade!
Its important to ask as many questions as possible especially if there is a certain process or piece of equipment that is of interest to you. I found it useful to put your auditor hat on during visits as this will help you to identify areas of risk and can lead to discussions over critical control parameters and in-process tests. With my visit to the high speed packaging line it was useful to relate that process to the manual packaging process I was used to. Ultimately the same controls are in place - the only significant difference was the volume and automation used in high speed lines.
'If you don't ask, you don't get'. If there is something you'd like to see, whether that is a SOP, deviation report etc then ask! I was lucky enough on one visit to be able to view a complete marketing authorisation. As my main experience has been with IMPs I had never seen a MA before and hence this was an obvious gap in my knowledge! This was asked for in advance by me and meant that this was scheduled into the itinerary. As a result I had the privilege to be talked through the MA contents by the company's PVQP.
6. Visit end
Ensure you get all the contact details from both the trainee QPs and qualified QPs on site. This will help build your network and if the trainee QP is a similar way through their training then it could be an opportunity to arrange regular telephone sessions. Always offer a reciprocal visit for their trainees to visit your own site.
Once back at base you should update your application form with what you have gained from the visit.
7. The reciprocal Visit
Arrange a reciprocal visit follows the same steps outlined above. Even though you may think you wont have much to offer someone from 'big pharma' remember that those trainee may have only ever experienced high volume pharmaceutical manufacturing. I have hosted a few visits of commercial pharma trainees and I think they gained something by reviewing small scale IMP manufacture and specialist equipment such as laminar cabinets & isolators.
Hosting visits is a really good way of validating your own knowledge in your systems & processes. It is almost like being audited especially if the visiting trainee QP is bombarding you with questions! Make the most of this as one of these questions may crop up during your viva. Again, include some scenario questions, real-life deviations and how they were dealt with during the visit. It is a good opportunity to see how someone other than your sponsor tackles specific problems.
Summary
Visits are an important part of your QP training. You should aim to make the most of your time on site with arranging itineraries before hand and identifying the main objectives of your visit. Witnessing first hand enables you to visualise processes, equipment and their associated noise, smell and scale - far better than any book or lecture could.
I have been very fortunate to have been on a number of visits to commercial pharmaceutical companies. Personally I think coming from the NHS helps for once as we are not a commcercial competitor and the NHS for many companies is a large customer and therefore are often willing to give something back. I have to thank the following companies for hosting me (and feeding me!); Teva, Rosemont, Eisai, Guy's Hospital, Amdipharm/Mercury Pharma & Wockhardt.
If anyone would like to visit my facility please feel free to contact me via this blog or my Linked In profile.
Study Toolbox Part 1: The Onion
Study Toolbox Part 2: Introduction to Mindmaps
Study Toolbox Part 3: Keeping up to date
Study Toolbox Part 4: Training Courses
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