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Training

Your quality assurance program must also include adequate training of your staff, and this should be clearly documented. Regulators will expect to see evidence that staff are competent at the function(s) they perform.

 

It is likely that a large component of the training your operators receive is practical, due to the nature of their jobs. However, they must also understand the regulatory requirements that apply in your establishment and why compliance is so important.

How can we help?

ResLabQ&C offers regulatory training courses that provide guidance on best practice and the knowledge and understanding that is essential to ensure compliance from your workforce. Our courses are suitable for both large and small establishments and can be delivered on site, remotely, or on-line (e-learning).

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Because of the dry subject matter, and because it is necessary to impart a substantial amount of theoretical knowledge, ResLabQ&C have developed their training courses to ensure they are engaging and actionable. They are designed to be interactive, and incorporate practical experiences, real life scenarios, and quizzes. Delegates are encouraged to share experiences and best practice.

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You also have the option of training being delivered in stages. This may be less disruptive operationally and may also help with the retention of higher amounts of necessary information.

Courses and their content

Good Clinical Laboratory Practice (GCLP) training

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  • Background to GCLP

  • Organisation and personnel

  • Contracts and agreements

  • Trial conduct

  • Patient/subject safety

  • Informed consent

  • Sample receipt and handling

  • Assay validation

  • Repeat analysis

  • Data reporting

  • Facilities

  • Equipment maintenance

  • Computerised systems

  • QA and QC processes

  • Policies and SOPs

  • Blinding/unblinding

  • Retention of data

  • Preparation and distribution of clinical kits

HTA training (research)

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  • Regulations (and why)

  • Licensing

  • Relevant material

  • Informed consent

  • Research ethics

  • Procurement

  • Sample management

  • Quality management

  • Ensuring compliance

HTA training (application)

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  • Regulations (and why)

  • Licensing

  • Quality management

  • Donor selection, evaluation, and screening

  • Informed consent

  • Procurement

  • Preparation process and validation

  • Storage and release

  • Distribution

  • Traceability and coding

  • Serious adverse events

  • Third party agreements

  • Storage

  • Distribution

  • Import/export

  • Ensuring compliance

Like what you see? Get in touch to learn more.

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