Pharmaceutical Supply Chain Management Training Course: Regulations & Compliance

Introduction

In the highly regulated pharmaceutical industry, ensuring pharmaceutical supply chain management adheres to strict regulations and compliance is paramount for patient safety and business integrity. This training course, "Pharmaceutical Supply Chain Management: Regulations & Compliance Training Course," equips professionals with the essential knowledge and skills to navigate the complex landscape of regulatory requirements. We delve into the intricacies of Good Distribution Practices (GDP), serialization, track and trace, and quality management systems, empowering you to build a compliant and secure supply chain. By mastering these strategies, you'll minimize risks, prevent counterfeiting, and ensure the safe and timely delivery of pharmaceutical products.

This program focuses on actionable insights and practical application, enabling participants to develop and implement robust compliance frameworks tailored to the unique demands of pharmaceutical supply chains. We explore the latest advancements in digital track and trace technologies, regulatory reporting, and risk mitigation strategies, emphasizing practical case studies and interactive exercises. You'll learn how to measure and report compliance performance, engage stakeholders, and foster a culture of regulatory excellence within your organization, ultimately transforming compliance into a strategic advantage for your pharmaceutical supply chain.

Target Audience:

• Pharmaceutical Supply Chain Managers
• Regulatory Affairs Professionals
• Quality Assurance Managers
• Logistics and Distribution Managers
• Pharmacovigilance Professionals
• Compliance Officers
• Pharmaceutical Manufacturing Personnel

Course Objectives:

• Understand the fundamental regulations and compliance requirements in pharmaceutical supply chains.
• Learn how to implement Good Distribution Practices (GDP) effectively.
• Master the techniques of serialization and track and trace for product integrity.
• Develop skills in managing and reporting regulatory compliance.
• Learn how to implement and maintain quality management systems (QMS).
• Understand the role of risk management in pharmaceutical supply chains.
• Implement strategies for preventing and detecting counterfeit pharmaceuticals.
• Learn how to conduct regulatory audits and inspections.
• Develop skills in navigating international pharmaceutical regulations.
• Analyze the impact of regulatory compliance on supply chain efficiency.
• Understand the ethical considerations in pharmaceutical supply chain management.
• Develop strategies for continuous improvement in compliance practices.
• Stay updated with the latest trends in pharmaceutical supply chain regulations.

DURATION

5 Days

COURSE CONTENT

Module: Foundations of Pharmaceutical Supply Chain Regulations:

• Overview of key regulations and compliance frameworks.
• The importance of regulatory compliance in pharmaceutical distribution.
• Key drivers and trends in pharmaceutical supply chain regulations.
• Understanding the impact of non-compliance on patient safety and business.
• The role of regulatory compliance in achieving supply chain integrity.

Module: Good Distribution Practices (GDP) Implementation:

• Implementing GDP guidelines and best practices.
• Managing temperature-controlled logistics and storage.
• Ensuring proper documentation and record-keeping.
• Implementing quality control procedures for distribution.
• Optimizing GDP compliance for efficient operations.

Module: Serialization and Track and Trace:

• Implementing serialization and track and trace systems.
• Utilizing unique identifiers for product authentication.
• Managing data integrity and security.
• Implementing electronic pedigree and traceability solutions.
• Optimizing serialization for supply chain visibility.

Module: Regulatory Compliance Management and Reporting:

• Developing and implementing regulatory compliance programs.
• Managing regulatory reporting and documentation.
• Utilizing regulatory compliance software and tools.
• Conducting regulatory impact assessments.
• Optimizing regulatory reporting for efficiency.

Module: Quality Management Systems (QMS) in Pharmaceutical Supply Chains:

• Implementing and maintaining QMS in pharmaceutical supply chains.
• Utilizing ISO 9001 and other relevant quality standards.
• Managing deviations and corrective actions.
• Implementing quality audits and inspections.
• Optimizing QMS for continuous improvement.

Module: Risk Management in Pharmaceutical Supply Chains:

• Conducting risk assessments and mitigation strategies.
• Managing supply chain disruptions and vulnerabilities.
• Utilizing risk management tools and methodologies.
• Implementing business continuity planning.
• Optimizing risk management for supply chain resilience.

Module: Preventing and Detecting Counterfeit Pharmaceuticals:

• Implementing strategies for preventing counterfeit pharmaceuticals.
• Utilizing anti-counterfeiting technologies and solutions.
• Managing product recalls and withdrawals.
• Implementing vendor qualification and due diligence.
• Optimizing anti-counterfeiting measures for product safety.

Module: Regulatory Audits and Inspections:

• Preparing for and managing regulatory audits and inspections.
• Conducting internal audits and self-inspections.
• Utilizing audit checklists and documentation.
• Managing audit findings and corrective actions.
• Optimizing audit readiness for compliance.

Module: International Pharmaceutical Regulations:

• Navigating international pharmaceutical regulations and standards.
• Managing import and export compliance.
• Utilizing harmonized standards and guidelines.
• Implementing global regulatory strategies.
• Optimizing international compliance for market access.

Training Approach

This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.

Tailor-Made Course

This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Training Venue

The training will be held at our Skills for Africa Training Institute Training Centre. We also offer training for a group at requested location all over the world. The course fee covers the course tuition, training materials, two break refreshments, and buffet lunch.

Visa application, travel expenses, airport transfers, dinners, accommodation, insurance, and other personal expenses are catered by the participant

Certification

Participants will be issued with Skills for Africa Training Institute certificate upon completion of this course.

Airport Pickup and Accommodation

Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Terms of Payment: Unless otherwise agreed between the two parties’ payment of the course fee should be done 5 working days before commencement of the training.