Paradigm Shift Consulting Limited offer a range of GDP training solutions, to fit all business models, and pockets.
Click <HERE> to see our next training dates.
Whether you are a pharmacy skimming model with a requirement for Responsible Person/RP refresher training or want Driver GDP training or Basic GDP Training for your new staff, we can help.
The EU guidance 2013/C 343/01 now states that regular training for staff and RPs is mandatory.
2.2. Responsible person
The wholesale distributor must designate a person as
responsible person. The responsible person should meet the
qualifications and all conditions provided for by the legislation
of the Member State concerned (1). A degree in pharmacy is
desirable. The responsible person should have appropriate
competence and experience as well as knowledge of and
training in GDP
(iii) ensuring that initial and continuous training programmes
are implemented and maintained;
All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks.
Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance
with a written training programme. The responsible person should also maintain their competence in GDP through regular training.
In addition, training should include aspects of product identification and avoidance of falsified medicines entering the supply chain.
Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products.
A record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.
This is now key….
- how do you check effectiveness of staff training?
- Are you or your RP competent to train your staff?
- Are you training “regularly?”
- Do you need specific training on Falsified Medicines?
- Do you read blogs like ours, attend regulatory conferences like the MHRA Symposia or HPRA Conferences?
With low recurrent service rates we can build in annual training to your costs.
For those with a larger site we offer;
- Driver GDP Training
- Warehouse Operative GDP Training
- Basic GDP Training for commercial staff
- Basic GDP Training for Accountants, HR Managers, IT Teams… all of your staff should know where their, and your, responsibilities lie
- Intermediate/Advanced/Refresher GDP Training for your managers or RPs and DRPs.
- GDP Training on Falsified Medicines or the Falsified Medicines Directive
- Cosmetics Regulations Training 1223 2009
Need something special?
We can also offer;
- Validation Training
- Temperature mapping training
- GDP Audit Training
- Third Party Logistics/3PL Auditing
- GDP Training for Subcontractors
or we can work to your agenda.
Have you had deviations or recurrent problems with particular members of staff? We can retrain and coach them into better working practices.
Remember that it is often the process, and not the person, however it is often the training methods or continuity that can be an issue.
Need SOP Training? QMS Support? We do that to.
Whatever GDP Training you need, contact us for a free, no obligation consultation.
We offer training regularly at our offices in Northamptonshire, client sites or via webinar.
Remember that group sessions often cost less, and give more interaction and learning opportunities.
Welcome to a new Paradigm!