Author

Walid El Azab

One-Day

Intensive Training

Attendees:

This course is essential for practicing Qualified Persons (QPs), individuals on a QP career path, and professionals within Quality Assurance, Quality Control, and batch release functions who need to understand the QP's critical role. It is suitable for beginner, intermediate, and expert levels.

Abstract:

This focused one-day training provides a critical update on the evolving regulatory landscape and its direct impact on the role and responsibilities of the Qualified Person (QP). Designed for both experienced QPs and those preparing for the role, the session begins by clarifying the legal foundations and specific duties of the QP, including batch certification, the Written Confirmation, and the boundaries of task delegation. The core of the training delves into a practical review of essential Good Manufacturing Practice (GMP) requirements that the QP must oversee, such as quality systems, supplier audits, deviation management, process validation, contamination control strategies, and serialization. Furthermore, it addresses navigating complex professional scenarios, including the QP's relationship with senior management and the use of external consultants. Through interactive group discussions and practical case studies, this seminar empowers attendees to not only fulfill their compliance obligations but also to drive continuous improvement within their organizations, ensuring they can confidently certify batches in an environment of constant regulatory change.

Learning Objectives:

Upon completion, participants will be able to:

• Articulate the legal and specific regulatory responsibilities of the Qualified Person.
• Distinguish between core QP duties that cannot be delegated and support tasks that can be assigned.
• Evaluate key GMP requirements (e.g., supplier qualification, deviations, process validation, contamination control) from the QP's certification perspective.
• Navigate specific professional situations, including interactions with senior management, use of external QPs, and managing absences.
• Apply knowledge through case studies to propose quality system improvements and maintain effective regulatory vigilance.

Walid El Azab

Industrial Pharmacist & Qualified Person (QP) | Senior GxP Consultant (17+ years) | Contamination Control & Sterility Assurance | Inspection Readiness & Auditing | Product Certification / Batch Release | Co-founder: QP Pro Services & QPM Consulting | Sterile & Non-sterile Process Validation | Upstream & Downstream Operations | ISPE • PDA • ECA • A3P Member | CCS ECA Task Force Lead | CCS A3P Working Group & PDA Journal Contributor | Co-founder: Belgium UPIP-VAPI QP Academy

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