Good Documentation Practices Skills Training Course

Ensuring data integrity is an important component of the pharma industry’s responsibility to guarantee the safety, efficacy, and quality of drugs. Violations relating to document management and data integrity have led to numerous regulatory actions, including warning letters and critical inspection findings. To address these concerns, the FDA, EMA, MHRA and the World Health Organization (WHO) have all recently published data integrity guidelines

Why You Need to Take This Training Course?

This course will provide YOU with three Benefits:

  1. Ensure Data Integrity and Regulatory Compliance: The course emphasizes the importance of data accuracy and completeness in the pharmaceutical industry. By learning proper documentation practices, you’ll gain the skills to ensure data integrity throughout its lifecycle. This can help your organization avoid regulatory violations and fines associated with poor documentation practices.

  2. Improve Documentation Efficiency and Accuracy: Upbeat Consult’s program focuses on practical techniques for clear, concise, and consistent record keeping. You’ll learn how to effectively complete, review, and approve documents, minimizing errors and omissions. This not only improves data quality but also saves time and resources in the long run.

  3. Boost Confidence in Audits and Inspections: Regular audits and inspections are a reality in the pharmaceutical industry. By mastering Good Documentation Practices, you’ll feel more confident during these processes. You’ll be equipped to demonstrate proper documentation procedures and answer questions about data integrity effectively.

What you'll learn

Instructor: Dr. Samer Sowidan

This 8-hour Training Course is Equivalent to 7 Continuing Professional Development (CPD) hours.

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