Training and Mentoring Support
Do your staff need training on an area where there is no “off the shelf” course available?
Do you think your junior staff would benefit from mentoring or on the job training either in general regulatory affairs or a specific process?
Tailor made on-site training
Real Regulatory provides tailor made training programmes to the Medical Device and Pharmaceutical industries. These sessions are generally delivered on-site, making them both cost and time effective. Our courses are tailor made to address the particular demands of the sectors in which our clients operate.
Examples of our most popular courses:
- Risk management (ISO 14971) – Risk management techniques for medical devices – hazard identification, risk estimation/evaluation, risk control and effectiveness of controls
- Canadian Medical Device Regulations and CMDCAS – Canadian regulations and incorporation of requirements into ISO 13485 quality management systems
- EU Medical Device training (directive 93/42/EEC) covering classification of devices, CE marking and conformity assessment routes, elements of a technical file/design dossier (risk analysis, essential requirements, clinical data, harmonized standards, etc.) and medical device post-marketing surveillance/vigilance.
Mentoring for junior staff
Real Regulatory also provides mentoring to new or junior members of staff. Mentoring accelerates the training and induction phases, giving junior staff members the knowledge and the confidence they need to carry out their duties.
Our consultants introduce them to the complex and dynamic landscape of Regulatory Affairs and guide them through the initial phases of their regulatory work, ensuring continued compliance to company procedures. Mentoring takes place on-site initially and can be followed up by regular telephone conversations, as required.See our Frequently Asked Questions (FAQs)