Data Integrity Auditor Masterclass: 2-Day Online Training Course (Oct 15Th-16Th, 2025)

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The "Data Integrity Auditor Masterclass Training Course (Oct 15th-16th, 2025)" has been added to ResearchAndMarkets's offering.

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.

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'.

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

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

Key Topics Covered

Day 1

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 the 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

Day 2

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

For more information about this training visit

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