Qualification and Validation, Documentation, Data Logging, and Data Integrity, QMS and Control

Day 1 – 2nd September 2025

Course Title: Qualification and Validation in the Pharmaceutical Industry

Course Overview:

This one-day intensive training program provides an in-depth understanding of qualification and validation principles in the pharmaceutical industry. Participants will gain insights into regulatory requirements, industry best practices, and practical approaches to implementing qualification and validation processes. The course covers key aspects such as equipment qualification, process validation, cleaning validation, utilities and computerized system validation. Interactive discussions will enhance learning and application in a pharmaceutical manufacturing environment.

Course Objectives/Key Learning Outcomes:

By the end of this training, participants will be able to:

• Understand the fundamental concepts of qualification and validation in compliance with GMP (Good Manufacturing Practice) and regulatory guidelines (FDA, EMA, WHO, PIC/S).
• Differentiate between qualification and
• Explain the lifecycle approach to validation and its integration into pharmaceutical quality systems.
• Identify regulatory expectations and key industry guidelines (ICH, EU Annex 15, ISPE, USP).
• Develop and implement risk-based validation strategies and documentation.
• Understand the role of process validation, equipment qualification, process validation, cleaning validation, utilities and computerised system validation and its impact on product quality and patient safety.
• Gain practical knowledge on writing validation protocols and reports.
• Insights into Documentation and Compliance in Validation
• Recognize common challenges and troubleshooting techniques in validation.

Day 2 – 3rd September 2025

Course Title: Ensuring Compliance: Documentation, Data Logging, and Data Integrity in the Pharmaceutical Industry

Course Overview:

This comprehensive training provides pharmaceutical professionals with an in-depth understanding of Good Documentation Practices (GDP), Data Logging, and Data Integrity Compliance as per global regulatory expectations (FDA, MHRA, WHO, EMA, EU GMP). Participants will gain practical insights into ALCOA+ principles, data management best practices, and audit readiness, ensuring compliance with industry standards.

Course Objectives/Key Learning Outcomes:

By the end of this course, participants will be able to:

• Understand Good Documentation Practices (GDP) and its role in compliance.
• Apply ALCOA+ principles to maintain data integrity.
• Learn best practices for data logging in manufacturing and laboratory environments.
• Recognize data integrity risks and implement mitigation strategies.
• Prepare for regulatory audits by ensuring compliant documentation.
  Implement corrective and preventive actions (CAPA) for data integrity failures.

Day 3 – 4th September 2025

Course Title: Quality Management Systems – Risk Management – Risk Assessment and Control

Course Summary

This module provides participants with the skills & tools to develop and implement a systematic process for the assessment, control, communication & review of risks to the business as well as understand risks and mitigation via robust controls & methods as outlined below:

• The recognition of risks prior to potential events impacting the healthcare system will enable improved efficiency.
• Through the identification of hazards, evaluation of its risk, and the implementation of methods to avert the incident, potential harmful situations can be minimized.
• Upon identification of the risks, participants will also be taught to evaluate the risks which require interventions and those which are low risk.
• The importance of a risk plan will be discussed, for improved operations as well as legal purposes. The assessment will encompass all the teachings of the course to enable application in the real world of healthcare for improved risk management under the guidance of the facilitator.