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Computer Systems Validation (21 CFR Part 11)

Public Course

Computer Systems Validation (21 CFR Part 11)

This Computer Systems Validation (21 CFR Part 11) training course is a 2 Day public programme, designed to give attendees the basic principles in validating both computer hardware and software systems used in Manufacturing, QA and Regulatory control of processes and systems.

The Computer Systems Validation Programme will also look at the 21 CFR part 11 ruling by the FDA pertaining to Electronic Records / Electronic Signatures.

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Course Content:

  • Introduction & Course Objectives
  • Regulations and Guidelines for Computer System Validation:
    •  Current GAMP version a
    •  FDA and EU regulatory guidelines
    • FDA Guidelines Software validation
  • Electronic Signatures and Records:
    • Background & impact of the regulations ,
    • Regulations and practical implications,
    • How to assess relevant company systems/products for compliance
    • Implementing a validation program around a compliant package.
  • The Computer Validation Life Cycle:
  • Risk assessment of Computerised systems
  • Q&A
  • Conclude & Follow Up Process

This Computer System Validation training programme may be of interest to personnel in the Pharmaceutical / MedicalDevice / HealthCare / Engineering Sectors of the Industry who need to gain a solid foundation in the principles of GXP in a regulated environment and how to apply these to develop fully compliant systems.

No prior knowledge of Computer Systems Validation is necessary.

Classroom based, instructor lead, practical hands on course.

Product Description

Computer Systems Validation (21 CFR Part 11)

This Computer Systems Validation (21 CFR Part 11) training course is a 2 Day public programme, designed to give attendees the basic principles in validating both computer hardware and software systems used in Manufacturing, QA and Regulatory control of processes and systems.

The Computer Systems Validation Programme will also look at the 21 CFR part 11 ruling by the FDA pertaining to Electronic Records / Electronic Signatures.

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours