21 CFR Part 11 Electronic Records and Electronic Signatures

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The main objectives of this course are to give attendees a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). The course provides an overview of the FDA and European requirements with pract... Read More

The main objectives of this course are to give attendees a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. The course also covers the latest FDA Guidance on Electronic Records and Signatures. Quality Risk Management as applied to Electronic Records and Signatures and validation of systems that use ERES are also addressed.

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What's covered?

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Regulations for ERES
The course will cover in detail the requirements of 21 CFR Part 11, the US regulation covering Electronic Records and Electronic Signatures. What each clause of the regulation means and how it can best be complied with will be discussed and explained.

Guidance on 21 CFR Part 11
The FDA has issued detailed guidance on their expectations for the implementation of 21 CFR Part 11 and the level to which the regulation will be enforced. This course will explain this guidance in detail and propose a strategy for its application to both new and existing systems.

ERES Assessments
This section takes the participant through how an ERES assessment should be conducted and how the information gained from an ERES assessment should be used. It will involve practical examples that the participant can complete on the day, thus leaving them ready to complete ERES assessments once they return to their workplace.

Risk Assessment
The programme will cover the application of risk assessment to the management of Electronic Records and electronic signatures as required by 21 CFR Part 11 and the relevant guidance.

Validation
The programme will cover the validation of Computer Systems for Electronic Records and Electronic Signatures as required by 21 CFR Part 11 in line with GAMP 5.

Who should attend?

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Personnel in the Pharmaceutical/Medical Device/Healthcare sectors who need to gain a solid foundation in the principles and practice of Electronic Records and Electronic Signatures in a regulated environment.

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • State the principles of Electronic Records and Electronic Signatures.
  • Apply the requirements of 21 CFR Part 11 in relation to Electronic Signatures & Records.
  • Apply Quality Risk Management techniques ERES.
  • Conduct ERES assessments.
  • Complete validation of Electronic Records and Electronics Signature applications.

Who are the tutors?

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Duration
1 training day
Course Times

9.00am to 3.00pm

Delivery Mode
This programme is available In-House

21 CFR Part 11 Electronic Records and Electronic Signatures

Duration: 1 day
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