📝 General Introduction 

Compliance with international standards such as GMP (Good Manufacturing Practice), ISO (International Organization for Standardization), and FDA (U.S. Food and Drug Administration) is a cornerstone of quality, safety, and global recognition in healthcare and pharmaceutical institutions.

These standards are not just regulatory requirements—they are strategic frameworks that ensure operational excellence, patient safety, and market competitiveness. Implementing these standards requires a deep understanding of their principles, the ability to build integrated systems, and a commitment to continuous improvement and staff training.

In a rapidly evolving regulatory landscape, organizations must stay up-to-date with global requirements and be agile in adapting their processes to meet inspection and certification criteria.

This 5-day workshop is designed to equip participants with the knowledge and practical tools to apply GMP, ISO, and FDA standards effectively.

Through hands-on exercises, case studies, and expert-led sessions, attendees will learn how to build a robust compliance system that supports quality, safety, and international accreditation.

🎯 Target Audience

• Quality and compliance officers in healthcare and pharmaceutical institutions
• Production and operations managers in pharmaceutical manufacturing
• Pharmacists involved in regulatory documentation and oversight
• Internal and external audit professionals
• Students of pharmaceutical sciences and quality management

🎯 Expected Objectives

• Understand the requirements and scope of GMP, ISO, and FDA standards
• Apply regulatory compliance procedures in healthcare and pharmaceutical settings
• Develop policies and documentation aligned with international standards
• Manage internal and external audits effectively
• Foster a culture of quality and compliance across the organization

📚 Scientific Topics:

Module 1: Introduction to International Standards

Session 1: Overview of GMP, ISO, and FDA

• Key differences and objectives
• Relevance to healthcare and pharmaceutical sectors
• Link between compliance and quality

Session 2: Importance of Compliance in Healthcare Institutions

• Impact on patient safety
• Regulatory challenges
• Benefits of international recognition

Module 2: Implementing GMP Standards

Session 1: GMP Requirements and Best Practices

• Production and storage conditions
• Documentation and validation
• Operational risk management

Session 2: Building a GMP-Compliant System

• Policy and procedure development
• Staff training and engagement
• Internal audit and evaluation

Module 3: Applying ISO Standards

Session 1: ISO 9001 in Healthcare and Pharma

• Total quality management principles
• Process identification and control
• Performance measurement and improvement

Session 2: Integrating ISO into Operations

• Quality manual preparation
• Process review and optimization
• Document and record management

Module 4: Meeting FDA Requirements

Session 1: Understanding FDA Regulations

• Registration and licensing
• Documentation and reporting standards
• Inspection readiness

Session 2: Preparing for External Audits

• Managing regulatory visits
• Responding to findings
• System improvement based on feedback

Module 5: Building a Sustainable Compliance Culture

Session 1: Promoting Quality and Compliance Culture

• Staff involvement in decision-making
• Motivation and accountability
• Change management strategies

Session 2: Policy Development and System Sustainability

• Periodic system review
• Adapting to regulatory updates
• Designing a long-term compliance model