Compliance & Validation - Overview
A half day course for managers,
business process owners and users covering the essentials of computer
systems compliance and validation. No technical or software
development expertise is required.
Computer Systems Compliance &
Validation - Conventional Approach
A 2 or
3 day course covering the practical aspects of validating computer systems
and ensuring compliance with regulations in a non bureaucratic way. This
course applies the approaches described in the various GAMP Guides (ISPE).
Some knowledge of software development is recommended but not essential.
Computer Systems Compliance &
Validation - Process Based Approach
A 2 to
3 day 'hands on' course that shows you how to apply a process based approach
to compliance and validation. A process approach is advocated by many
sources such as the FDA, ISO, GAMP 5 but not many validation specialists
know how to adopt it effectively.
The
course covers process modelling, process based risk assessment and
management and software lifecycles from a process perspective. As it is
based on process modelling using BPMN
(BPMN training),
knowledge of this is required as a minimum pre-requisite.
Effective Processes and Procedures
using Process Modelling
A 1 day 'hands on' course for business
analysts, QA personnel and anyone developing or updating Standard Operating
Procedures (SOPs). Process Modelling using BPMN (BPMN training) to ensure accurate, effective and robust
processes and procedures are covered. No technical or software development
expertise is required. The key elements of BPMN modelling are included in
this course.
Requirements Analysis & Management
A 1 day course for managers,
business process owners, QA personnel and users covering the essentials of
capturing business and system requirements. No detailed technical or software
development expertise is required but is recommended.
Testing Strategies, Execution &
Management
A 1 day course for test managers,
business process owners, QA personnel and testers covering the essentials of
effective testing. Test Planning and Reporting, authoring compliant test
scripts and good test execution practice are covered in a practical manner.
No detailed technical or software
development expertise is required but is recommended.
Tailored Training and Coaching
Every
organisation is different, so we can tailor our courses supported by 'hands
on' coaching and consultancy to meet your
specific needs.
Please contact
us to discuss your requirements.