This comprehensive course has been crafted to deliver essential knowledge and practical skills in Good Distribution Practice (GDP) compliance, tailored for professionals in pharmaceutical wholesale distribution. Our aim is to support your career development in the highly regulated pharmaceutical distribution industry, while also ensuring you stay up-to-date with the latest HPRA guidelines and EU GDP standards which impact wholesale distribution authorisation (WDA) holders.
The course includes:
- Instructions on the requirements for a quality management system;
- How to conduct customer and supplier Bona Fides; how to manage outsourced activities including GDP auditing;
- how to manage complaints, recalls, falsified medicinal products & returns; how to apply for & vary a WDA;
- how to conduct & review temperature mapping & validation of warehouses & transport;
- The role of the Responsible Person.
- The course goes on to further include relevant legislation to each chapter in the EU GDP Guidelines and common deficiencies identified during GDP audits.
Price: €900
Course Overview
This course features in-depth modules covering:
- EU and National GDP Legislation & Guidelines
- The Bona Fides and The Responsible Person (RP)
- Complaints, Returns, Falsified Medicines and Product Recalls
- Maintaining Quality Management Systems
- Management of Outsourced Activities
- Temperature Mapping and Transport Qualification
- Competent Authority Inspections
- Applications and Variations for WDAs
- Unauthorised and Exempt Medicinal Products
Please note that information on controlled drugs and cold chain medicinal products is integrated into relevant modules. All GDP chapters are addressed and the following are featured within modules throughout the course, personnel, premises & equipment, documentation, operations and self-inspections. Specific provisions for brokers are addressed within EU GDP Legislation & Guidelines.
- Easy Enrolment
- Self Paced
- Online Learning
- Certificate
What This Course Offers
This course covers essential GDP topics, offering up-to-date insights from Irish and European legislation, HPRA and European guidelines, and FQS’s own extensive industry experience. Key components include:
- A thorough review of relevant GDP legislation and guidelines.
- Practical guidance on compliance, based on real-world experience from FQS RPs and DRPs in HPRA inspections and GDP audits.
- Training on temperature mapping and transport qualification, with focus on risk assessments, protocols, and report preparation.
- post-course consultation with an experienced RP, providing an opportunity for in-depth discussion and personalized guidance.
The course is structured for sequential completion, with quizzes at the end of each module or section to ensure comprehension. A 100% score is required to pass each quiz, with up to three attempts allowed. Upon completing all modules, you will receive a certificate.
Objective Of This Course
The objective of the FQS Responsible Person (RP) course is to develop skilled, knowledgeable professionals capable of ensuring full compliance with Good Distribution Practice (GDP) regulations in pharmaceutical distribution. By completing this course, participants will be equipped to:
- Understand and Apply GDP Legislation: Gain a thorough knowledge of EU and national GDP guidelines, including relevant directives, acts, and regulations.
- Ensure Compliance in Distribution: Learn best practices for maintaining the quality and safety of medicinal products throughout storage and distribution.
- Confidently Face Regulatory Inspections: Be prepared for HPRA inspections and GDP audits, understanding the documentation, processes, and standards required.
- Conduct Temperature Mapping and Transport Qualification: Acquire the skills to perform temperature mapping qualification studies, and risk assessments for both ambient and cold chain products.
- Manage Key Responsibilities of an RP: Develop proficiency in handling the responsibilities of an RP, including product quality management, and conducting audits and inspections.
By achieving these objectives, participants will be well-prepared to perform their roles as RPs, supporting compliance, quality, and regulatory excellence in pharmaceutical distribution.
Who is This Course For?
This course is designed for professionals in the pharmaceutical wholesale distribution and supply chain sectors who are responsible for, or interested in, ensuring compliance with Good Distribution Practice (GDP). It is particularly valuable for:
- Current and Aspiring Responsible Persons (RPs): Those designated to oversee GDP compliance within their organizations, or professionals aiming to step into this role.
- Quality Assurance (QA) Personnel: Individuals who play a role in maintaining quality management systems and need in-depth GDP knowledge.
- Regulatory and Compliance Managers: Those responsible for regulatory adherence within pharmaceutical distribution and ensuring practices align with EU and national standards.
- Pharmaceutical Logistics and Distribution Professionals: Team members involved in managing the storage, handling, and transportation of pharmaceutical products.
- Manufacturing and Operations Managers: Leaders overseeing operations that intersect with GDP, including third-party logistics.
- Continuous Professional Development (CPD) Seekers: Individuals seeking to update their knowledge and skills to align with the latest GDP guidelines and inspection expectations.
This course is ideal for professionals who want to deepen their understanding of GDP, confidently manage regulatory requirements, and maintain high standards of quality and safety in pharmaceutical distribution.
Requirements
There are no prerequisite requirements for completing this course.
