This advanced course provides a comprehensive understanding of pharmaceutical quality assurance and regulatory affairs. Participants will explore quality management principles, regulatory requirements, and the latest practices in ensuring pharmaceutical products' safety, efficacy, and quality. The course combines theoretical knowledge with practical applications, preparing professionals to navigate the complex landscape of pharmaceutical regulation and quality assurance.

Upon completion of this course, participants will be able to:

Understand the principles of pharmaceutical quality management.
Develop skills to ensure compliance with regulatory requirements.
Learn about the latest standards and guidelines in pharmaceutical quality.
Explore strategies for effective regulatory affairs management.
Enhance their ability to implement quality systems in pharmaceutical production.

This course is intended for:

Pharmaceutical quality assurance professionals
Regulatory affairs specialists
Pharmaceutical production managers
Compliance officers
Healthcare professionals involved in drug development
Graduate students in pharmaceutical sciences and related fields

The course employs a blend of instructional methods, including:

Interactive lectures
Hands-on quality management and regulatory sessions
Group discussions and case studies
Expert-led Q&A sessions
Comprehensive course materials and resources

Day 5 of each course is reserved for a Q&A session, which may occur off-site. For 10-day courses, this also applies to day 10

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ID	التواريخ المتاحة	المدينة	الرسوم	الإجراءات

Course Content

Section 1: Introduction to Pharmaceutical Quality Management

Overview of pharmaceutical quality management systems
Key concepts and principles of quality assurance
The role of quality management in the pharmaceutical industry

Section 2: Regulatory Frameworks and Requirements

Overview of global regulatory bodies and their requirements
Key regulatory guidelines: FDA, EMA, ICH
Navigating the regulatory submission process

Section 3: Quality Control and Assurance Practices

Good Manufacturing Practices (GMP)
Quality control methods and tools
Ensuring product safety and efficacy through quality assurance

Section 4: Risk Management and Compliance

Identifying and managing risks in pharmaceutical production
Strategies for maintaining compliance with regulatory standards
Case studies of compliance challenges and solutions

Section 5: Practical Applications and Future Trends

Implementing quality systems in pharmaceutical production
Emerging trends in pharmaceutical quality and regulation
Collaborative problem-solving and case studies
Course review and expert Q&A

Certificate Details

عند إتمام هذه الدورة التدريبية بنجاح، سيحصل المشاركون على شهادة إتمام التدريب من Holistique Training. وبالنسبة للذين يحضرون ويكملون الدورة التدريبية عبر الإنترنت، سيتم تزويدهم بشهادة إلكترونية (e-Certificate) من Holistique Training.

شهادات Holistique Training معتمدة من المجلس البريطاني للتقييم (BAC) وخدمة اعتماد التطوير المهني المستمر (CPD)، كما أنها معتمدة وفق معايير ISO 9001 وISO 21001 وISO 29993.

يتم منح نقاط التطوير المهني المستمر (CPD) لهذه الدورة من خلال شهاداتنا، وستظهر هذه النقاط على شهادة إتمام التدريب من Holistique Training. ووفقًا لمعايير خدمة اعتماد CPD، يتم منح نقطة CPD واحدة عن كل ساعة حضور في الدورة. ويمكن المطالبة بحد أقصى قدره 50 نقطة CPD لأي دورة واحدة نقدمها حاليًا.