Training Courses
GAMP® Overview Courses
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.
Generic Courses
Management of GxP Documentation
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.
Change
Management
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.
Inspection Readiness
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.
Risk Management – Science Based Approach
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 Analysis, and FMEA - Failure Mode
and Effects Analysis.
21 CFR Part 11
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 analyse your records, define requirements, conduct
assessments and help mitigate any risks or gaps in system processes
or functionality.
Legacy Systems and Retrospective Validation
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.
Testing
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.
Network and Infrastructure Qualification
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.
System Specific Courses
Enterprise
Resource Planning Systems (ERP)
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.
Process Control Systems
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.
Manufacturing
Execution Systems (MES)
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.
Enterprise
Asset Management Systems (EAMS)
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.
Electronic Document Management System (EDMS)
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.
Laboratory Information Management Systems
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.
Laboratory Automated Systems
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.
Warehouse Management
System (WMS)
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.
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