Responsible Person for GDP

Program

Implementation of the New EU GDP Guideline

• Well-known or new: a summary of the most important changes

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GDP Compliance: How to Achieve It?

• Roadmap: what do I need?

• How to get started and to maintain a GDP-compliant status?

• The counterfeit and pharma supply chain

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Quality Management System

• How to develop and implement an effective Quality Management System?

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Roles and Responsibilities of the RP

• Qualification requirements to the RP

• Duties of the RP

• How to keep it all under control?

• What and how to delegate?

• How to report and control delegated activities?

• RP deputy: who can help me?

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RP Quality Oversight: Principles & Practical Approach

• RP Quality Oversight: what to oversee and how to proceed?

• How to establish a Quality Oversight process

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Batch Release for Sale: Requirements & Reality

• Batch release for sale: is this mandatory?

• Batch release for sale: to do or not to do?

• What does Final Batch Release mean for RP?

• RP vs. QP role in Final Batch Release

• Where your responsibility as RP GDP stops

• How to identify what to verify and control?

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Returns: Time- & Risk–reducing Approach

• What are the requirements and how to implement?

• Time- & risk-reducing approach

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GDP(/GMP) Inspections

• GDP inspection readiness

• Frequent findings

• Expectations with regards to the RP

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Temperature-controlled Distribution

• Get to know your distribution chain

• How to identify the weakest links and what to do?

• How to manage cold chain products: warehousing & transport

• How to manage 15-25°C products: warehousing & transport

• Temperature monitoring or control? – what is the best option for the product

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How to Manage Outsourced GDP Activities & GDP Audits

• What is a GDP activity?

• How to qualify & manage GDP outsourced activities?

• Approach a GDP Audit

• Reporting deficiencies : CAPA’s or risk mitigation plan?

• Quality Agreements requirements & inspectorate expectations

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Transport: a Grey-zone or Well-known Activity

• How to manage GDP-transport?

• Risk-based approach and where to pay attention to

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Management Review & Monitoring in Practice

• How to identify the parameters for monitoring

• The Best Industry Practices for Management Review and Monitoring

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