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Ensuring Data Integrity in Pharmaceutical Operations

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This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

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Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Data integrity has been a focus for pharmaceutical regulatory inspections for several years. Many inspection reports from regulatory agencies such as the FDA and EMA cite data integrity as a cause of observations and enforcement action. In serious cases regulators ceased commercial activities of manufacturers on the grounds of data integrity violations.

 

This data integrity training course explains the background to data integrity regulations and sets out the expectations of pharmaceutical regulators. It will provide you with the knowledge and practical skills to implement data integrity best practice. Ultimately the aim of this course is to minimise any data integrity issues or violations by maintaining high quality data integrity processes. The course explains how to take a risk-based approach to data integrity compliance, electronic record keeping (GAMP 5) ALCOA for pharmaceutical records and conducting your own data integrity audits.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

 

  • Understand what data integrity is and why it is important for patient safety and product quality.
  • Recognise that there are many causes of data integrity breaches.
  • Be aware of current regulatory expectations such as GAMP 5 and ALCOA.
  • Appreciate the difference between static and dynamic records and be able to apply acceptable strategies for the retention of both types of record.
  • Be able to categorise and validate GxP computerised systems according to GAMP 5.
  • Understand the importance of training and quality culture in avoiding regulatory enforcement action.
  • Learn how to respond to data integrity observations in inspection reports.
  • Discover how to prevent, detect and remedy data integrity problems

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Day 1

Historical background and data integrity definitions

  • Data integrity and patient safety/product efficacy
  • The evolution of GxP regulations – driven by both criminal activity and honest mistakes
  • The US FDA’s debarment policy
  • Evolution of data integrity guidances
  • Introduction to GAMP 5
  • Early data integrity cases

 

Regulatory expectations

  • ALCOA and ALCOA+
  • Static and dynamic records
  • Essential elements of data governance
  • Non-conformance trends
  • Data integrity controls
  • Data integrity risks in sample analysis and production
  • Investigating data integrity problems
  • Metadata, audit trails and audit trail review

 

Data integrity risk assessment

  • Quality risk management: ICH Q9
  • Risk management process
  • Approaching a data integrity risk assessment
  • Controlling risk in computerised systems
  • Configuration and life cycle management
  • Operating system and application software considerations

 

Computerised systems

  • Audit trails, access controls and user permissions
  • Excel spreadsheets – practical advice on the appropriate use, validation and control of Excel spreadsheets
  • Introduction to computerised data system validation

 

Extracts from regulatory enforcement letters

 

Addressing data integrity problems

 

Day 2

Managing computerised data systems

  • Guidance
    • 21 CFR Part 11
    • EU Annex 11
    • GAMP 5
  • Examine the detailed practices recommended by GAMP 5
  • Life cycle management and risk assessment
  • Supplier assessment

 

Computerised system validation

  • Validation planning
    • Policy
    • Plans
    • Documentation
  • System description
  • Introduction to software testing

 

Conducting a data integrity audit

  • Planning the audit
  • Conducting the audit
    • Policies, procedures, practices
    • Training
    • Quality culture
  • Evaluating quality risk
  • Mitigating data integrity risks

 

Managing client audits and regulatory inspections

  • The importance of data integrity risk assessments/action plans
  • The audit/inspection process
  • Client audits
    • Confidentiality
    • Result checking and reporting
  • Regulatory inspections
    • Behaviour during inspection
    • Responding to non-conformance observations

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.

 

In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.

 

Mark has delivered numerous training courses on data integrity, helping professionals and organisations to understand the latest guidances and implement best practice. He provides expert advice in all areas of data integrity such as regulatory guidances, audits, GAMP 5 and risk assessments. He has conducted data integrity audits in the UK, continental Europe and the United States. Mark draws on his extensive experience and provides multiple examples throughout the course. He has recently co-authored a data integrity guide in collaboration with the laboratory supplier and instrument manufacturer VWR.

This course is aimed at professionals who work with data in a regulatory GxP environment such as the pharmaceutical, biotech or medical device industries. These include: Quality | Laboratory Personnel | Production Personnel | Analysts | IT/IS Managers | Regulatory Affairs | Documentation Departments.

 

The following sectors would benefit from this course: Pharmaceutical | Biotechnology | Medical Devices | API Manufacturers | Contract Laboratories | Clinical Research Organisations.

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