people development
Integrity Soloutions offer satndard and custom training programmes
to meet the specific objectives of your organisation. With
our hands on experience of European and U.S. regulation, coupled
with our in-depth knowledge of industry best practice gained
through participation in industry forums, we are able to provide
the appropriate business and technical focus to suit the varying
needs of delegates.
Management Seminars
Management seminars focus on the business need for pharmaceutical
validation, outlining the regulatory requirements of key markets
and the business benefits that can be gleaned from effective,
scaleable validation practices. Case studies are used in order
to heighten awareness of the potential cost of non-conformance.
Open dialogue provides managers with the opportunity to share
issues and obtain insight into proven strategies for addressing
such issues.
Technical Awareness
Technical awareness training provides insight into the principles
of pharmaceutical validation. These training courses can be
offered for control and information systems. From this training,
delegates will gain insight into European and US regulatory
requirements, validation lifecycles, documentation requirements,
roles and responsibilities, user and supplier relationships
and ongoing management of validation during the operational
phase.
Technical Skills
Technical skill training builds on the technical awareness
training or current knowledge of delegates to provide in-depth
understanding of validation practices. The course defines
a scaleable risk based approach to validation, promoting validation
strategies for a range of systems within the corporate computer
system hierarchy from Spreadsheets to Enterprise Resource
Planning Systems. Strategies address standardisation, size,
complexity and business risks associated with the implementation
of computerised systems. Delegates will learn how to:
 Interpret
current regulation
Develop
robust User Requirements
Conduct
Supplier Audits and Manage shortfalls in supplier capability
Manage
Multiple Suppliers
Conduct
Technical and Project Risk Assessments
Plan
Risk Management Strategies
Manage
Design, Installation, Operational and Performance Qualification
Report
Validation Activities
Establish
and maintain operational compliance
Training
Change
Control and Configuration Management
Disaster
Recovery and Business Continuity
System
Archive and Restoration
Maintenance
Planning
Security
Periodic
Review and Revalidation
Custom Training
Maximum benefit can be obtained by customising a standard
training course to meet the specific environment within which
your organisation operates. Our consultants will meet with
management and other personnel in order to conduct a training
needs analysis in order to focus training on the current competency
of the organisation, business operations and processes, computer
systems and current topical issues within the organisation.
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