Data Integrity Training Course

Data Integrity Regulations (Intensive Training Course for Industry Professionals and Business Owners)

Overview of the Data Integrity GMP Compliance Course

In the fast-paced and highly regulated world of pharmaceuticals, maintaining impeccable data integrity isn’t just a best practice—it’s a critical regulatory requirement that underpins the safety, efficacy, and compliance of every medicinal product. Data integrity ensures that all information related to the development, manufacturing, testing, and distribution of pharmaceuticals is accurate, reliable, and trustworthy.

Data integrity is not merely about maintaining records; it is about upholding the highest standards of quality throughout the entire product lifecycle, and it is a crucial element of complying with the law. 

Regulatory bodies such as the FDA (Food and Drug Administration), TGA,  APVMA, EMA (European Medicines Agency) and other Authorities have stringent guidelines and regulations in place to enforce data integrity. Data integrity requirements for pharmaceutical and medical device manufacturers and veterinary medicines manufacturers aim to prevent inaccuracies, omissions, and fraudulent practices that could compromise patient safety and public health.

Pharmaceutical industry companies, including laboratory scientists, business owners, senior managers, quality personnel, operations personnel, and responsible persons, must implement robust systems and procedures to secure data from unauthorized access, modification, or deletion, thereby guaranteeing the authenticity and traceability of all critical information.

Beyond regulatory compliance, the significance of data integrity in the pharmaceutical industry extends to ensuring the reproducibility of research findings, facilitating timely decision-making, and supporting continuous improvement in manufacturing processes. Accurate data serves as the foundation for making informed scientific conclusions, validating product quality, and responding swiftly to any deviations or adverse events.

Prioritizing data integrity isn’t just a matter of meeting regulatory expectations—it is pivotal to safeguarding public health and patient safety for humans and animals; maintaining consumer trust, and advancing pharmaceutical innovation.

FDA data integrity guidelines, ICH, APVMA regulations, data security scientific data integrity

Data integrity is not new. It is implicit, and always has been, as a foundation of good manufacturing practice (GMP). 

The subject of data integrity, however, has an increased profile because hybrid (paper and electronic), digital technologies and electronic systems have become prevalent in modern manufacturing.

Globally regulators are recruiting and training their Regulatory Compliance Inspectors in data integrity.  During GMP compliance audits, Inspectors are identifying increasing numbers of GMP violations linked to data integrity.

  • This one-day Data Integrity training course is regularly offered via ZOOM and/or in Adelaide, Brisbane, Melbourne, Perth and Sydney (Australia) and in Auckland (NZ) and nearby regions.
  • The course is designed to provide an overview of the latest concepts and guidance documents for Data Integrity including the FDA Data Integrity and Compliance with cGMP Guidance for Industry and regulations along with cGMP compliance guidance found in PIC/S GMP Guides, and the US FDA’s 21 CFR 11 and 211, and other guidance documents on data integrity such as from the EU/EMA, TGA, APVMA, and other regulators.

Training in Data Integrity responsibilities (a 1-Day intensive GMP Certificate training course in Data Integrity regulations)

This Data Integrity training course offers a practical insight into data integrity, what it is and how you can develop systems to help protect your employees, your organisations, and patients from deliberate and unintentional data integrity compliance issues.

What you will learn in our 1-Day Data Integrity training course:

Upon completion of this data Integrity training course participants will understand;

  • What is data integrity and why is it important
  • Deep dive into FDA warning letters regarding data integrity breaches
  • The ALCOA principles of good documentation practice (GDocP)/good recordkeeping practice (GRK)
  • Relationship between good documentation practices and data integrity
  • Data integrity in laboratories
  • Issues related to a lack of data security, data falsification, testing into compliance, and other illegal activities regarding data collection, storage and analysis
  • Data security measures/data governance requirements including restricting user access, data access privileges, audit trails, archiving and retrieval
  • Embedding data integrity measures into your quality management and pharmaceutical quality management systems (it is not a stand-alone policy but is integral to every aspect of quality control and patient safety)!

The course is designed around case studies so you can practically apply theory to real life in your job role and manufacturing, testing, and/or distribution company.

GMP Certificate Training & Course Materials

  • Participants in this training course will receive a copy of the copyrighted presentation(s), relevant notes and workshop materials.
  • Online Final Assessment (must be completed within 7 days)
  • A certificate of completion will be issued to participants who successfully complete the assessment.

Course format

  • The course is a combination of lecture-style learning and highly interactive workshops with participants working in small groups on assigned tasks.
  • This 1-day intensive training course covering data integrity GMP compliance is offered via ZOOM or via classroom style training.
  • You can also contact us to discuss onsite GMP training courses for 10 or more employees, subject to scheduling availability.
  • An online assessment should be completed following the course (within 7 days) to earn your GMP Training Certificate for this Data Integrity course.

Who should attend this Data Integrity regulatory compliance training course?

  • Quality Assurance personnel
  • Pharmacovigilance Professionals
  • Laboratory Scientists
  • Customer Service Personnel
  • Quality Control personnel
  • Business owners and Senior Management
  • Operations and Manufacturing personnel
  • Qualification/Validation personnel
  • Engineering & Automation personnel
  • Regulatory Affairs personnel
  • Anyone within the GMP industry interested in learning about or improving their knowledge of current PIC/S GMPs.

AUD$500.00 + 10% GST Full Day Virtual Training

AUD$550.00 + 10% GST Full Day Classroom Training

Prices are per person and include morning tea, lunch and afternoon tea (excluded for Virtual Training).

Register for a Data Integrity Training Course below:

If you need any assistance, would like a quote for personalised group training or just have a general training question don’t hesitate to contact us using our enquiry form.