Why is Competency Based Training Important?
It is essential that every member of staff is confident in their role and understands how to follow procedures to effectively complete tasks in accordance with what is set out in the GDP guidelines, and competency must be evidenced.
They must all be considered competent and compliant.
If this is not the case, or if something goes wrong, they will need training on any areas they do not understand to improve their knowledge and competency.
We offer bespoke competency based training packages, helping you create a course that is tailored to exactly what areas need to be covered for your employees to get the information they require.
How to Show Competency
Competency can be shown in a number of ways including:
– Before and After tests that are completed when on a training course to show how much has been learnt (improvement in marks).
– Asking questions to test their knowledge ensuring that they don’t need a refresher session.
– Observing/monitoring them whilst working to make sure that they are following procedures correctly.
There must be evidence of the competency of all staff members that can be shown during an inspection.
Evidence and Records
This means that you need to keep records of anything that shows that each individual has taken competency based training courses – e.g. any certificates they have gained from training and their training plan with a list of the courses they have successfully completed.
This will also need to include any training that has been given on the company’s own processes, procedures, documents and equipment.
You must ensure that the RP and management team have had further training that goes into more detail about all areas of GDP as they will need be able to guide the other members of staff and are responsible for the compliance of the company.
Any personnel that work with products/equipment that require specialist handling must have specific training that covers the procedures needed to ensure they are handled (and stored) correctly.
If this does not happen it may negatively impact the integrity of medicinal products which causes a potential threat to patient safety.
Further Assistance and Support
All staff will need regular refresher training to ensure that they are up to date and confident with the guidelines as well as the company’s operations/equipment/documents – we recommend that this happens at least annually.
Further training will be required if they take on a new role or tasks, if new procedures/processes are introduced within the company or if any legislation/guidelines have changed.
Take a look at our online training courses or contact us at info@gdptraining.co.uk to attend one of our face-to-face courses.
Alternatively, simply message us from the contact form below.
Certificates are supplied when you have passed any of our courses, and both pre and post training tests are taken to show improvement of knowledge from the training. These can be used as evidence of competency based training.
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Related Courses
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In order to purchase, store, import, export or supply medicinal products a company must be in possession of a Wholesaler Dealers Authorisation (WDA) issued by the HMRA. A WDA cannot be issued without a Licence Holder having been nominated by the company.
In this training course we will cover the obligations of a Licence Holder with regards to EU Good Distribution Practice (GDP) Guidelines and Human Medicines Regulations 2012.
By the end of the course, you will have a thorough understanding of the role and responsibilities of the Licence Holder and how you as a Licence Holder can ensure full compliance with the guidelines and regulations in your organisation.
Introduction to Pharmacovigilance in Good Distribution Practice
This course provides a comprehensive overview of pharmacovigilance (PV) within the context of Good Distribution Practice (GDP) in the UK and EU. It is designed for persons involved in supply chain, quality, and distribution roles, including Responsible Persons.
Key learning areas include the management of spontaneous safety reports, the implementation of additional risk minimisation measures, the execution of patient support programmes, and the importance of regular data reconciliations and audits. Ultimately, you will understand how to maintain compliance and fulfil pharmacovigilance obligations within Good Distribution Practice.
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Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) came into force on November 5th, 2013, with the HMR2012 harmonising with the EU guidelines post-Brexit. Any person acting as a wholesale distributor must hold a wholesale distribution authorisation (WDA) and must comply with the guidelines for, and principle of GDP. No one is permitted to handle medicinal products without suitable GDP training, which must be submissible as a current certificate. This course includes additional information on the disapplication of the FMD. Guidelines on the Windsor Framework are also accessible.
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The pharmaceutical global supply chain sees the flow of medicinal products around the globe, from API’s (active pharmaceutical ingredients) imported from one country, packaged in another, and re-exported world-wide, or simple business to business transactions of a finished product.
This course will help you fully understand the distribution process, attain the level of quality risk management that meets GDP regulatory requirements, and thus ensure the lowest possible risk to patient safety.
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The addition of regulation 45-AA outlines the new requirement for the UK WDA (H) licence holder to appoint (and have available) a Responsible Person for import. The RPi will be approving importation from listed countries by performing checks for appropriate evidence, to confirm that each production batch of a medicine (imported from an approved country for import under the licence) has been certified as provided for in Article 51 of the 2001 Directive, or such equivalent certification procedure as applies in the approved country for import.
Medical Devices Awareness Training
There are a wide range of medical devices available on the market, for example a walking stick, contact lenses, breast implants, surgical instrument or a hospital bed. A medical device is any apparatus, appliance, software or material, whether used alone or in combination, or intended by the manufacturer to be used by human beings for a medical purpose.
This introductory training course will provide you with sound information of medical devices, classes, classifications, and an understanding of ISO 13485. There are millions of medical devices available in the world today, with 600,000 in the UK alone.
Warehouse Operational GDP & Thermal Compliance
Warehouse Operational GDP & Thermal Compliance is of critical important to the quality, efficacy and safety of the product and consequently, to the patient - the end user. For any warehouse to meet the standards of compliance expected, it is essential that all areas of operation are engaged correctly, fully and in accord with the established SOP's and QMS (Standard Operational Procedures and Quality Management System).
Pest Control Training
The Pest Control training course introduces you to the ever-present problem of pest control in warehouses and stores. It is for all members of staff (including management and RP’s) actively engaged in the handling, storage and transportation of pharmaceutical products and medical devices in all premises where such activity is licenced. Pestilence ingress can cause great damage and great cost to a wholesaler; take this course to be aware of what you can do, and how.
Introduction to Management of Controlled Drugs
The training will provide a brief overview of the current legislation and good practice guidance relating to controlled drugs (CDs) in a wholesale/supply environment. It will outline your obligations and responsibilities as a licence holder (WDA, CD licence) in the management of CDs. It will also cover the common deficiencies found by Regulators from previous inspections.
Unlicensed Medicines
The Unlicensed Medicines course covers QMS, manufacturing, quality trending, Licenses, clean room requirements, QA, handling and storage, raw material supplies and more. You will also learn about regulations and the Law for ULM handling and storage/supply, including import/export requirements.
Driver Training
The Driver Training Course is for all drivers, logistics personnel and transport/shipping supervisors involved in the vehicular transportation of medicinal products, and will help you attain GDP awareness and compliance observance.
It is during the transportation of medicines that the products are at highest risk. This course provides tuition on how to minimise risk to the products when in transit, and how it should be handled.
Good Distribution Practice – Change Control
A Change Control with a quality management system (QMS) is a formal process used to ensure that changes to a product or system are introduced in a controlled or coordinated manner. As nothing should be changed without documentation, this course will explain how to engage a change control correctly and in a manner that is conducive to GDP Compliance.
Online GDP Webinar – GDP for RPs and Management
An intensive one-day webinar covering all the chapters of the EU GDP Guidelines for RPs and Management. A successful pass on the final exam (hand-marked by us) will provide a certificate as evidence of training to a current and high standard.
Data Integrity
This online Data Integrity course is aimed at new starters and existing staff as part of their ongoing Data Integrity training. This course provides a practical overview of the challenges and potential areas of non-compliance that are inherit within paper-based, electronic and hybrid data systems.
Non-Conformance And Deviation Management (GDP)
Discover the elements and requirements of a compliant Non-Conformance and Deviation management system. This programme aims to focus on the critical elements of the Non-Conformance and Deviation process and on implementation, correct procedure, where it could go wrong, risks and correct documentation.
Warehouse Cleaning and Personnel
Keeping licensed premises clean and hygienic to a standard that meets GDP compliance, is an ongoing task. The Warehouse Cleaning and Personnel course covers all aspects of cleaning and hygiene in a licensed warehouse, and help you and your cleaning team to be efficient in the cleaning procedures, thus aiding compliance to Good Distribution Practice, as well as helping to maintain the Quality Management System (QMS).
Outsourced Activities and Responsibilities of the Licence Holder and Responsible Person
This course looks at Outsourced Activities relating to Good Distribution Practice, along with the Responsibilities of both the Responsible Person and Licence Holder. Including areas such as the quality system and risk management with details from the Human Medicines Regulations and the EU Guidelines on GDP.
Introduction to Auditing
Discover the elements and requirements of Auditing. This programme aims to focus on the critical elements of the auditing process, showing you what to look for and to identify problems in the QMS or GDP of a licensed premises.
Falsified Medicines
Detecting Falsified Medicines could be said to be an "art" all in itself. Most are very convincing and extremely difficult to spot. The Falsified Medicine course will show you what to look for in order to positively identify a Falsified Medicine, and what the correct procedures are in order to correct deal with them.
GDP for RPs and Management
GDP for RPs and Management covers topics that will help you with GDP compliance, such as Falsified Medicines, Deviations and Documentation. It gives more detail on what is included in the EU Guidelines 2013/C 343/01.
