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Data Integrity Auditor Masterclass Training Course

During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.

24-25 July 2024
+ 17-18 October 2024 »

from £1299

Need help?  Enrol or reserve

Course overview

Data integrity has received more attention than ever before in the last decade and has become the most critical audit topic for health authorities. Although data integrity has started to gain importance in recent years, its history dates back approximately 30 years. Data integrity breaches at Barr Laboratories and later Able reveal this issue is older than it seems. As the health authorities began to question data integrity in audits more and more, pharmaceutical manufacturers started to increase their focus on data integrity, especially in GMP audits, and they started to seek ways to train their internal audit teams with this in mind. This approach acts to detect the deficiencies and deviations that will be found in internal audits prior to the health authority audits.

Although there are numerous data integrity training courses available, the training rarely discusses the audits in detail, which leaves companies trying to solve their problems with a little guesswork based on their own knowledge and experience.

In this course, the concept of data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed. The programme will also advise in which departments data integrity audits should be carried out. Data integrity audits of the; warehouse, production, quality control, quality assurance, critical utilities, and engineering departments in pharmaceutical production facilities will be covered, with sample applications and question lists, and the most critical audit findings encountered in health authority audits will be examined. During this two-day training programme, the participants will analyse case studies and scenarios, which will aid the learning process.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

  • Learn the requirements of data integrity audits and health authority expectations
  • Evaluate the concept of data integrity from a completely different perspective
  • Understand the requirements of the role and necessary skills of the data integrity auditor
  • Explore how to audit and prepare for external data integrity audits in the following departments; warehouse, manufacturing, quality control, quality assurance, critical utilities, and engineering.    

At the end of the course, there will be a short assessment exam with case studies and audit scenarios which will be analysed during the course, and those delegates who are successful in the assessment exam will receive the title of ‘Certified Data Integrity Auditor’.

Who should attend?

Personnel from the following departments will benefit from this course:

  • Quality assurance and quality control
  • Validation
  • R&D
  • Audit
  • Regulatory
  • IT
  • Warehouse and supply chain
  • Engineering
  • Procurement 

As well as:

  • Health authority inspectors

Enrol or reserve

This course will cover:

Welcome and introduction

GMP guidelines and regulations for data integrity (DI)

  • Pharmaceutical Inspection Co-operation Scheme (PIC/S), EU, WHO, MHRA, FDA data integrity regulations
  • Parenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE)
  • Association for Professionals in Infection Control (APIC), International Pharmaceutical Excipients Council (IPEC) Guidelines
  • Regulatory inspection – focus on data integrity (DI)
  • How to prepare your facility for regulatory inspection
  • How to prepare SMEs for DI questions

Data integrity principles

  • What is ALCOA and ALCOA + (Attributable, Legible, Contemporaneous, Original & Accurate)
  • Beyond ALCOA

Data integrity Issues in pharmaceutical companies

  • How to manage DI in manufacturing
  • How to manage DI in laboratories
  • How to manage DI in warehouse & logistics
  • How to manage DI in the supply chain

FDA's pre-approval inspection (PAI) and data integrity issues

  • What is the most important thing in PAI and DI?

Audit planning and team building

  • How to prepare a risk based DI audit plan?
  • How to select DI audit team?
  • How to be a good DI auditor?

Hints, tips and clues to performing successful DI audits

Virtual DI audits

  • DI Gap analysis
  • DI checklist

Workshop 1: data Integrity sourcing to laboratory equipment

Recap of day one

DI auditing of warehouse and critical utilities

DI auditing of manufacturing

  • DI auditing of calibrations 

DI auditing of an analytical chemistry laboratory

  • Chromatography data system
  • Chromatography falsification
  • DI audit of stability
  • Can we audit audit trails?
  • Can we detect DI risks?

DI auditing of a microbiology laboratory

  • DI auditing of endotoxin testing
  • Revealing DI breaches in a microbiology laboratory

Supplier DI auditing

  • API DI audits
  • Excipient DI audits

Electronic records and electronic signatures (ERES) DI auditing

  • Standard operating procedure (SOP) for electronic audit trail review
  • Audit trail review – Fourier Transform Infrared (FT-IR)
  • Audit trail review questions
  • E-records self-inspection

IT Infrastructure and cloud DI auditing

  • System security, data generation, back-up and spreadsheets
  • Stand alone systems, and DI audits

Workshop 2: data falsification investigation

DI audit report preparation and distribution

Case Studies and lessons learnt from regulatory inspections

Exam

Enrol or reserve

Mustafa Edik

Mustafa Edik is an Independent GMP Consultant and Auditor.  

After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry. 

He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.

While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.

He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.

 

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

24-25 July 2024

Live online

09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 14273

  • GBP 1,499
  • EUR 2,099
  • USD 2,338

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Not ready to book yet?

for 7 days, no obligation

17-18 October 2024

Live online

09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 14274

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 12 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

United Kingdom

  • TC BioPharm
  • TC BioPharm Limited

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy