Techdow is defined as an independent training provider (Centre Number 31136) by Highfield Qualifications.

This policy explains how Techdow Pharma England manages the accredited training content published and certified through the Highfield Qualifications Awarding Body.

Scope

All training formally accredited via Highfield Qualifications, for which TECHDOW provides the educational content.

TECHDOW provides training in the correct use of INHIXA®, thromboembolic diseases and the prevention of needlestick injury.

Definitions

Sustainability

The accredited training is comprised of practical, onsite training, followed by an online training and examination. Fully trained healthcare professionals should ensure a more sustainable clinical approach through less wastage of incorrectly used doses of medicine, reduced incidence of needlestick injury and fewer adverse events related to incorrect use.

The onsite training requires the travel and physical presence of a TECHDOW training representative to physically train about the correct use of the INHIXA®. The onsite training visits should be arranged to ensure that emissions in relation to staff business travel are no higher than absolutely necessary. In addition, the provision of training materials online and electronic issue of the qualification help to make the training process more environmentally sustainable and reduce use of resources related to travel and printing.

1. Our Approach to Quality and Standardisation

a. The framework of our Quality Management System is outlined in our quality manual, which establishes and maintains an environment of compliance and continuous improvement.

b. The Quality Management System is the responsibility of TECHDOW senior management and is subject to quarterly review of performance metrics, legislative changes, specific issues and items of importance to the compliance and operation of the business, including risk management.

c. The quarterly review is attended by the TECHDOW QLT, a multi-functional, senior management-level team.

d. As per pharmaceutical industry requirements, TECHDOW maintains records of all activities within the Quality Management System, including the QLT meeting, for a minimum of five years.

e. All policies and procedures which form the TECHDOW Quality Management System are subject to periodic review, with either an annual review or a biennial review, depending on the document type and criticality.

The review date is stated on the policy or procedure document and logged in the SOP Logbook, which is reviewed on a monthly basis by the Quality function.

2. Monitoring and Feedback for Accredited Training

a. The feedback form should be emailed to each hospital that has received training, with a request to obtain feedback from the trainees. Feedback will be sent to the RP.

b. Feedback may also be received directly by TECHDOW, via the Medical Information team. Feedback will be sent to the RP from the Medical Information Team. The RP also has direct access to the Medical Information database and email inbox.

c. The RP shall raise the feedback at the Quality Leadership Team meeting and determine whether updates are required to the accredited training materials or other elements of the course.

The discussion and outcome will be minuted, with any actions assigned to the RP or appropriate delegate.

The QLT Meeting Template includes a section for accredited training feedback and review.

3. Complaints

a. Trainees wishing to raise a complaint about the training or the exam are directed to Medical Information in the online training. Medical Information will send the complaint to the RP for a response.

b. The RP will log all complaints in the Accreditation Complaints Register).

c. An acknowledgement will be sent to the person raising the complaint withing two working days.

d. The RP will promptly investigate all complaints and respond via email to the person raising the complaint.

Complaints should be managed via the Deviations procedure and any corrective or preventive actions that are identified through the deviation should be explained in the email response to the person raising the complaint.

Investigations should ideally be completed within 30 days of the complaint being raised, wherever possible, but it is more important to conduct a full and thorough investigation, which may take longer to complete properly.

The response email will also provide details on how to raise an appeal with Highfield Qualifications, should the person raising the complaint be dissatisfied with the response.

4. Appeals

a. Persons appealing an exam result will initially be notified that they can retake the exam, as there is no limit on re-takes. The RP will verify if they still wish to raise a complaint. If the person still wishes to raise a complaint, this will be handled via the complaints process detailed in Section 3.

b. All complaint response emails will provide information on how to appeal in cases where the person is dissatisfied with the TECHDOW response.

The response email will provide signposting that in the event a trainee wishes to appeal a decision or response made by TECHDOW, they can contact the examination board (Highfield Qualifications) at info@highfield.co.uk.

The trainee should also be informed that in the event they are not satisfied with the response from the examination board, they can escalate their issue to the regulatory body Ofqual (https://www.gov.uk/government/organisations/ofqual/about/complaints-procedure).

5. Accredited Material Publication, Review and Update

a. As per pharmaceutical industry requirements, all materials for accredited training must be certified via our copy approval process (SOP-040) prior to publication.

Copy approval requires review and formal sign off by the Managing Director, a copy approval medic (pharmacist) and the RP.

A re-review of all copy certified through the copy approval process must be conducted every two years as a minimum, to ensure the material is still current.

Full records of copy review and certification, including and re-reviews, are retained for a minimum of five years.

b. The RP must also ensure that any proposed updates to the accredited training materials or exam questions are circulated to Highfield Qualifications for review and approval.

c. Publication of accredited materials is managed by Highfield Qualifications, in accordance with their own procedures.

6. Staff knowledge and internal training on procedures and policies

a. All TECHDOW employees retain a formal training record.

b. All roles within TECHDOW are recorded on the Training Matrix and personnel in those roles are trained on relevant quality standards, policies and procedures as identified and defined in the training matrix.

Training for all staff is refreshed annually for identified relevant quality standards and whenever an identified, relevant procedure or policy is newly published/updated.

The effectiveness of training for quality standards and procedures is assessed via a training exam, as defined in the Training procedure.

Current versions of policies, procedures and training courses on quality standards are published on the TECHDOW intranet for reference.

In addition, professional roles within the pharmaceutical industry, such as the RP role, have an associated legal requirement to attain a certain level of continued professional development points each year.