McDowall Consulting

McDowall Consulting offers services to clients in several areas: Pharmaceutical, Medical Device and Biotechnology Organisations Writing or Reviewing 21 CFR 11 policies for organisations and the integration with their existing computerised system validation (CSV) policies. Developing or reviewing 21 CFR 11 assessment checklists of equipment and syst... ems. In-house awareness seminars on the 21 CFR 11. These are typically a day but can be longer and are customised to a client's individual requirements and needs. The basis for the course can be downloaded as a file link to 21 CFR 11 training course. Training your Organisation's 21 CFR 11 Compliance Assessment Teams. This in-company course is linked to an organisation's policy for ER/ES and equipment and it can be tuned for GLP, GMP or GCP emphasis. We start with a lecture style for an understanding of 21 CFR 11 requirements, then move into group evaluation of systems and finally each individual assesses a system followed by a group discussion of the results. Confidence in assessment of systems is a key outcome of this course as well as completed assessments for several systems by the attendees themselves. link to 21 CFR 11 assessment training Audits of 21 CFR 11 Assessments. An external quality assurance check of any on-going work can be provided to a client to confirm that assessments are consistent and effective; alternatively, suggestions for different approaches can be given.Read More