Annette Callaghan Limited provides healthcare manufacturing companies with high quality, concise and instructive training to enhance regulatory compliance.
These courses can be “off the shelf” or may be structured and tailored to address the specific needs of your staff, providing you with a broad portfolio of skills, so that you can effectively meet the challenges of UK and EU regulations.
Many of our experienced trainers are Notified Body Lead Auditors, or Qualified Persons, with extensive background knowledge of the medical device and pharmaceutical industries and the practical application of quality management system methodologies.
Our courses address the practical ways in which your organisation can comply with many regulatory standards, such as:
- EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
- EN ISO 14971:2012 – Medical devices – Application of risk management to medical devices
- EN ISO 11137-1:2015 – Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- EN ISO 11137-2:2015 – Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
- EN ISO 11135:2014 – Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
- EN ISO 17665-1:2006 – Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- SOR/98-282 – Canadian Medical Device Regulations
- EU Good Manufacturing Practice and Good Distribution Practice for medicinal products
4 X 90 Taster Courses- In-House Management Training
Annette Callaghan Limited brings you a new concept in training:
- Are you fed up with long, overly complicated and irrelevant training courses?
- Are you an experienced manager, but new to the medical device industry?
- Would you like a broader understanding of a variety of disciplines?
- Would you like to update your regulatory knowledge?
- Would you like to keep your staff disruption to a minimum?
- Would you like to assess your or your staff’s current knowledge, without spending all of your training budget?
If the answer is “Yes” to any of these questions, choose our 4 x 90 minute option, which allows you to choose modules from the available list of courses and select whichever combination suits your company. We also offer a confidential pre-course assessment to enable tailor-made courses.
You could opt for:
- 4 x 90 minutes on the same topic, allowing only a quarter of your delegates away from their posts, at any one time.
- 4 x 90 minutes on up to 4 different topics, with either the same or different delegates within each group
- A split day with 2 x 90 minutes modules in each half, on 2 topics of your choosing.
Course examples:
- Senior Management Regulatory Responsibilities
- CE Marking
- ISO 13485:2016 Overview
- 2017/745 EMDR update
- Risk Management
- Good Manufacturing and Distribution Practice
- Clean Room Principles
- CAPA and Root Cause Analysis
Please contact us to discuss your requirements for in-house training and we will provide you with a personalised quotation
