Introduction

The pharmaceutical and healthcare industries operate under an exceptionally stringent and continuously evolving regulatory environment, driven by the critical imperative of patient safety and public health. From drug development and clinical trials to manufacturing, distribution, and post-market surveillance, organizations must demonstrate unwavering adherence to complex global standards. This essential training course focuses on Pharmaceutical and Healthcare Compliance Auditing, equipping professionals with the critical knowledge and practical methodologies to effectively assess, monitor, and enforce regulatory compliance across the entire healthcare product lifecycle. You will gain expertise in navigating crucial frameworks such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), pharmacovigilance regulations, and patient data privacy laws (e.g., HIPAA, GDPR), ensuring the integrity and safety of healthcare products and services.

This intensive training course delves into the intricate details of compliance auditing within both the pharmaceutical and healthcare sectors, covering the nuances of quality management systems (QMS), risk-based auditing approaches, and the verification of controls designed to prevent fraud, waste, and abuse. We will explore the roles of key global regulatory bodies such as the FDA, EMA, and WHO, and discuss how to audit against their specific guidelines. Participants will gain hands-on experience in planning and executing compliance audits, identifying non-conformities, conducting root cause analysis, and preparing comprehensive audit reports that drive corrective actions and foster a robust culture of compliance. By the end of this training course, you will possess the expertise to confidently lead pharmaceutical and healthcare compliance audit engagements, safeguarding patient trust and ensuring your organization's ethical and legal standing in this highly scrutinized industry.

Target Audience

• Compliance Officers (Pharmaceutical & Healthcare)
• Internal & External Auditors
• Quality Assurance & Control Professionals
• Regulatory Affairs Specialists
• Pharmacovigilance Professionals
• Clinical Research Coordinators & Managers
• Legal Counsel (Healthcare Focus)
• Risk Management Professionals

Course Objectives

• Understand the fundamental concepts of pharmaceutical and healthcare compliance.
• Learn about the global regulatory landscape impacting these industries (e.g., FDA, EMA, WHO).
• Master methodologies for auditing Good Manufacturing Practices (GMP).
• Develop skills in assessing adherence to Good Clinical Practices (GCP) in clinical trials.
• Understand the requirements and auditing of Good Distribution Practices (GDP).
• Learn about techniques for auditing pharmacovigilance systems and adverse event reporting.
• Explore best practices for auditing patient data privacy and security (e.g., HIPAA, GDPR).
• Master techniques for assessing quality management systems (QMS) in pharmaceutical and healthcare settings.
• Understand the compliance risks associated with marketing, promotion, and anti-bribery/corruption in healthcare.
• Learn about preparing comprehensive compliance audit reports and corrective/preventive actions (CAPA).
• Apply practical Pharmaceutical and Healthcare Compliance Auditing strategies to real-world scenarios.

Duration

5 Days

Course Content

Module 1: Introduction to Pharmaceutical & Healthcare Compliance

• Defining compliance in pharmaceutical and healthcare sectors.
• Exploring the critical role of compliance in patient safety and public trust.
• Understanding the complex ecosystem of regulatory bodies and industry standards.
• Overview of common compliance challenges and their consequences (e.g., fines, recalls).
• The ethical imperative of robust healthcare compliance.

Module 2: Regulatory Frameworks (GMP, GCP, GDP) Audit

• Learning the principles and requirements of Good Manufacturing Practices (GMP).
• Mastering methodologies for auditing GMP compliance in manufacturing facilities.
• Understanding Good Clinical Practices (GCP) for ethical and scientific clinical trials.
• Techniques for auditing GCP adherence in clinical research.
• Exploring Good Distribution Practices (GDP) for secure supply chains.

Module 3: Pharmacovigilance and Post-Market Surveillance Audit

• Understanding the purpose and requirements of pharmacovigilance systems.
• Learning about adverse event reporting and signal detection.
• Mastering techniques for auditing pharmacovigilance processes and data integrity.
• Assessing post-market surveillance activities for medical devices and drugs.
• Ensuring compliance with global reporting obligations.

Module 4: Patient Data Privacy & Cybersecurity Audit

• Exploring major patient data privacy regulations (e.g., HIPAA, GDPR).
• Understanding the principles of protected health information (PHI).
• Techniques for auditing data security controls and privacy safeguards.
• Assessing incident response plans for data breaches.
• Ensuring ethical data handling in research and patient care.

Module 5: Quality Management Systems (QMS) Audit

• Mastering the implementation and auditing of Quality Management Systems (QMS) (e.g., ISO 13485, ISO 9001 in healthcare).
• Understanding the components of an effective QMS.
• Techniques for auditing document control, training, and internal audit processes.
• Assessing management review and continuous improvement initiatives.
• The role of QMS in overall compliance assurance.

Module 6: Marketing, Promotion & Anti-Bribery Compliance

• Learning about regulations governing marketing and promotion of pharmaceuticals and medical devices.
• Understanding anti-kickback statutes and anti-bribery regulations (e.g., FCPA, UK Bribery Act) in healthcare.
• Techniques for auditing promotional materials and physician interactions.
• Assessing controls to prevent improper payments and inducements.
• Ensuring transparency in financial relationships with healthcare professionals.

Module 7: Audit Planning, Reporting & Remediation

• Strategies for planning and scoping pharmaceutical and healthcare compliance audits.
• Mastering techniques for conducting effective audit interviews and evidence collection.
• Preparing clear, concise, and actionable compliance audit reports.
• Developing and tracking Corrective and Preventive Action (CAPA) plans.
• Best practices for communicating audit findings to stakeholders and regulators.

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 10 working days before commencement of the training.