Compliance with International Standards (GMP, ISO, FDA)
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 instit
- 5training days
- 5modules
- 10sessions
- 30topics
About the programme
Course Overview
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.
Expected Learning Outcomes
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
Who Should Attend
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
Course Modules
Open any module to see its sessions and topics.
01Introduction to International Standards
Session 1Overview of GMP, ISO, and FDA
- Key differences and objectives
- Relevance to healthcare and pharmaceutical sectors
- Link between compliance and quality
Session 2Importance of Compliance in Healthcare Institutions
- Impact on patient safety
- Regulatory challenges
- Benefits of international recognition
02Implementing GMP Standards
Session 1GMP Requirements and Best Practices
- Production and storage conditions
- Documentation and validation
- Operational risk management
Session 2Building a GMP-Compliant System
- Policy and procedure development
- Staff training and engagement
- Internal audit and evaluation
03Applying ISO Standards
Session 1ISO 9001 in Healthcare and Pharma
- Total quality management principles
- Process identification and control
- Performance measurement and improvement
Session 2Integrating ISO into Operations
- Quality manual preparation
- Process review and optimization
- Document and record management
04Meeting FDA Requirements
Session 1Understanding FDA Regulations
- Registration and licensing
- Documentation and reporting standards
- Inspection readiness
Session 2Preparing for External Audits
- Managing regulatory visits
- Responding to findings
- System improvement based on feedback
05Building a Sustainable Compliance Culture
Session 1Promoting Quality and Compliance Culture
- Staff involvement in decision-making
- Motivation and accountability
- Change management strategies
Session 2Policy Development and System Sustainability
- Periodic system review
- Adapting to regulatory updates
- Designing a long-term compliance model
Complete your registration
We will contact you within one business day to confirm.