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Document Management and Data Integrity


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Who should attend?

This course is designed for managers and staff from clinical research and other GXP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and reporting of data to ensure Data Integrity, including, Clinical Trials, Manufacturing, Pharmacovigilance, QC/QA and QA personnel from CROs and CMOs. GXP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from this course. Relevant roles include those working in: Clinical research Regulatory affairs Quality assurance / quality control Legal and compliance office Compliance manager GMP compliance officers Heads of internal audits

Details

Data Integrity is a critical issue in document governance. Document Management and Data Integrity are increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Course Overview

Data Integrity issues can apply to all life science industry sectors where data is required to fulfil regulatory requirements, including clinical trials, pharmacovigilance and manufacturing. This concise course will provide an essential understanding of the requirements for ensuring data integrity and effective Document Management in order to maintain compliance with the new regulatory requirements in this area.

Topics to be covered Include:

  • Principles of Good Documentation Practice (GDP) and data integrity
  • Compliance with Good Documentation Practices for linked paper and electronic records
  • Regulatory guideline requirements in the EU, UK, FDA and WHO

Why you should attend

Document Management and Data Integrity are increasingly becoming a focus for regulatory inspections globally. Data Integrity issues can apply to all life science industry sectors where data is required to fulfil regulatory requirements, including clinical trials, pharmacovigilance and manufacturing. Data Integrity issues from inspection findings have resulted in a marked increase over recent years in both EU non-compliance reports and FDA warning letters, as regulators are concerned about Data Integrity failures in poor documentation. Regulators, including the FDA and MHRA have reacted to this by issuing guidances that contain provisions on Data Integrity and documentation. This concise course will provide an essential understanding of the requirements for ensuring Data Integrity and effective document management in order to maintain compliance with the new regulatory requirements in this area.

 

Prices

GBP 699.00 EUR 979.00 USD 1,090.00 + VAT @ 20.00%

Contact

Leigh White
info@management-forum.co.uk

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