21 CFR Part 11 Electronic Records and Electronic Signatures

This programme is available In-House and currently delivered through virtual classroom training.

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.

Delivery Mode

  • Customised
    In-Company
    Programmes

    Contact Us

SnapshotSnapshot

Course Code
LS001

What's covered?

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 participate?

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?

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?

John Lafferty

John Lafferty is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry. John joined SQT as a tutor in 2007. Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and Regulatory Systems. John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting. “It is great to be able to bring this knowledge, and the experience gained from ongoing involvement with Life Sciences companies, into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices. As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

John holds the following qualifications: a Bachelor of Technology in Manufacturing Technology, a Six Sigma Black Belt, a Certificate in Training & Continuing Education and a Certificate in Quality Management. John is a member of the following committees relating to Risk Management of Medical Devices; ISO TC 210 – Medical Devices Technical Committee and CEN/ISO JWG1 – Joint Working Group on Risk Management.

One of John’s greatest achievements, in recent years, has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.


John Lafferty

Hide

John Lafferty

Duration: 1 day
Hide

Contact SQT today