Cost Effective Training

An overview of GAMP^®5. An introduction to the principles of validation and the application of these principles, allowing us to focus attention on those areas of computerised systems that most impact patient safety, product quality, and data integrity. The short half day course is an introduction to the concepts and framework of recently released GAMP^®5. The full day course looks more in- depth at each section of GAMP^®5, with examples, and the 'dos and don'ts' of systems validation. Real industry examples and 'lessons learnt' are described.

An introduction to the control and management of GxP Documentation. Ideal for new starters or equally as a refresher for those having worked in a GxP Regulated Environment before. The Management of GxP Documentation training course is also a useful precursor to the Electronic Document Management Systems (EDMS) Module.

A look at development and application of a Change Management process to demonstrate control over changes made to computerised systems, to include software, hardware and documentation. It considers the controls required during the computerised system development phase, and the on-going change control process throughout the system lifetime.

This course helps to train and prepare delegates for Regulatory Inspection. These inspections are often treated with complacency by staff who are inexperienced in communication during an inspection. The course discusses what auditors are looking for and how best to prepare for this. It discusses how all staff, including those not necessarily "fronting" it, should behave during an audit. It talks about the importance of communication and presentation, and particular aspects such as Audit Trails, Risk Management and Periodic Reviews. By supplying you with practical examples and templates based on GAMP^®5, the course will demonstrate how to prepare indexes, reports and other supporting evidence. By attending this course and applying the principals discussed, there is an increased likelihood that your systems and organisations will be INSPECTION READY.

A Risk-based approach to validation, as advocated by the FDA, is beneficially being adopted by many of the major pharmaceutical companies who can focus valuable resources where the risk is higher. This course looks at a scalable Science-based approach to Risk Management and discusses the recommended requirements of a Risk Management process and gives examples of processes successfully adopted. Course talks about standard methods used across the industry such as FTA – Fault Tree Analisys, and FMEA - Failure Mode and Effects Analysis..

Our Consultants have been heavily involved with ISPE GAMP^® initiatives on Part 11 and the evolving regulatory interpretation. We therefore have a good insight into the regulatory requirements necessary for Computerised Systems to meet compliance with the ruling, and we have significant experience of helping our clients achieve compliance. This practical GAMP^® based course explains the ruling and the very latest interpretation and guidance material. This will help your staff get a better insight into how to determine which records are within the scope of the ruling, how to apply a records risk based approach, how to manage and analyze your records, define requirements, conduct assessments and help mitigate any risks or gaps in system processes or functionality.

Application of the principles of validation to legacy computerised systems. How to demonstrate that an existing system is fit for purpose, and how and what to test during retrospective validation.

A practical approach to testing based on GAMP^®5 is explained. The principles of testing are defined within this course along with examples of forms and templates that enable the user to successfully test and qualify the systems that they implement.

A practical approach to infrastructure management and qualification is discussed. Definition of Platform Qualification (vs. System Qualification) and the advantages this brings are described. Procedures for maintaining the qualified status are described, in particular Change Management, Security, User Access Management, Backup and Recovery, Data Archiving and Problem Resolution.

This module provides an approach to validation based on GAMP^®5 during all phases of an MES project. Real examples and templates are made available to delegates which will enable them to plan, design, implement, validate and maintain an MES project throughout the project or system life cycle.

A pragmatic application of GAMP®5 principles to Process Control Systems used to manage Pharmaceutical production processes, providing a scalable validation solution to integrated and embedded systems alike. Particular areas of discussion include Planning, Risk Assessment, Specifications and Formal Testing and Reviews.

This training course offers an introduction to Enterprise Asset Management Systems, including the benefits of such a system. Sometimes called Maintenance Management Systems these systems are used to store critical information such as calibration data, maintenance and cleaning schedules. Guidance is given on how and why to validate EAMS, with examples provided.

A full introduction to EDMS including what they are, how they can contribute to an organisation, basic principles of how they work and how they fit within an Enterprise Content Management System. This module provides a pragmatic approach to validating an EDMS based on GAMP®5 through all phases of a project. The course also includes practical tips on how to specify and select a system, potential pitfalls during an implementation, and how to test, validate and assess the performance of a system. The course is independent of specific system solution and includes a short review of the EDMS market for those yet to select a system.
The one-day course can be adapted to fit half a day for those seeking a brief overview, but with less detail on document lifecycles and workflows, and testing and validation requirements.

Use of LIMS offers a high degree of flexibility and functionality to the management of laboratory information and data. This course includes an introduction to LIMS functionality and interfacing with other software packages.

As laboratory systems become more sophisticated, it is important to consider the qualification/validation requirements. The Laboratory Automated Systems module covers Equipment Qualification through to the validation of Data Acquisition Systems, such as Chromatography Data Systems. This module also takes a look at the validation requirements of equipment-system interfacing.

A Warehouse Management System automates and optimises material handling processes. The business benefits by improved efficiency, which allows the business to offer improved, accurate and innovative services to the customer. This module offers guidance in specification, vendor selection and validation planning of a Warehouse Management System. In particular, documenting the implementation and validation efforts to required regulatory standards within GAMP®5 are covered.

This course details how to validate an ERP system. The course can be tailored to be a generic look at ERP Systems, or a more focused review of some of the major systems, such as SAP or ORACLE.