Real-World Quality Management Systems and Data Integrity Compliance Tactics

In today’s paperless, cloud-based environment, maintaining control over data and quality systems is tougher — and more important — than ever. For companies regulated by the FDA, one small oversight in documentation, digital systems, or audit preparedness can result in major regulatory setbacks.

This webinar cuts through the noise and breaks down what really matters when it comes to Quality Management Systems (QMS) and data integrity. You’ll learn how to manage digital records securely, avoid common compliance risks, and align with FDA’s 21 CFR Part 11 — all without over-complicating your operations. We’ll also walk through what to expect in a remote audit, and how to be truly ready for it.

Whether you’re managing quality, compliance, IT, or data systems, this session gives you the clarity and strategy needed to meet today’s regulatory demands confidently.

WHY YOU SHOULD ATTEND

QMS and data integrity aren’t just buzzwords. They’re the foundation of your company’s compliance and reputation. If you're using electronic systems — whether on-site or in the cloud — and you’re dealing with FDA oversight, you can’t afford to get these things wrong.

This session is designed for professionals who want straight answers on how to keep their digital records clean, validated, and audit-ready. You’ll understand what FDA expects when it comes to 21 CFR Part 11, how to prevent data tampering, and how to handle remote inspections without scrambling at the last minute.

We’ll also cover practical tips for managing audit trails, electronic signatures, system validation, and how to build a workplace culture where data integrity is part of the everyday routine — not just a compliance checkbox.

Join us to strengthen your company’s compliance posture and keep your systems (and your team) inspection-ready.

AREAS COVERED

• Overview of Quality Management Systems (QMS):
  • Key components and structure of a QMS in FDA-regulated manufacturing.
  • Role of QMS in ensuring product quality and regulatory compliance.
• Understanding Data Integrity in Pharmaceutical and Medical Device Manufacturing:
  • Defining data integrity and its impact on product quality and compliance.
  • Ensuring the accuracy, completeness, and reliability of data across the product lifecycle.
• FDA’s 21 CFR Part 11 Compliance:
  • Key requirements for electronic records and signatures under 21 CFR Part 11.
  • Ensuring audit trails, data security, and preventing data manipulation.
• Managing Electronic Records and Digital Systems:
  • Best practices for electronic record-keeping, including cloud-based and on-premise systems.
  • Validating digital systems to ensure compliance with regulatory standards.
• Cybersecurity Measures for Data Protection:
  • Strategies to protect digital records from breaches, data manipulation, and unauthorized access.
  • Implementing encryption, access control, and other security features.
• Remote Audits and Virtual Inspections:
  • Best practices for conducting and preparing for remote audits.
  • Maintaining data integrity and compliance during virtual inspections.
• Audit Trails and Documentation Requirements:
  • Ensuring accurate and secure audit trails for both manual and electronic data.
  • Techniques for tracking changes and providing transparent documentation.
• Addressing Data Manipulation Risks:
  • Identifying common risks of data manipulation and falsification in digital environments.
  • Implementing controls to mitigate the risk of data tampering.
• Training and Building a Culture of Data Integrity:
  • Ensuring proper training for staff on data integrity principles.
  • Establishing a culture of accountability and compliance within the organization.

WHO SHOULD ATTEND

• Quality Assurance Departments
• Regulatory Affairs Departments
• Compliance  Departments
• IT Managers and Systems Administrators
• Data Integrity Managers
• Validation Engineers and Specialists
• Auditors (Internal and External)
• Manufacturing Departments
• R&D Managers and Scientists
• Cybersecurity Professionals

Course Director: MEREDITH CRABTREE

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.