Professional Certificate in Pharma QA and Regulatory Affairs
-- viewing nowThe Professional Certificate in Pharma QA and Regulatory Affairs is a comprehensive course designed to provide learners with critical skills in quality assurance and regulatory affairs, essential in the pharmaceutical industry. This program emphasizes the importance of compliance, good manufacturing practices (GMP), and regulatory strategies to ensure pharmaceutical products' safety, efficacy, and quality.
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Course Details
• Introduction to Pharma QA and Regulatory Affairs: Roles, responsibilities, and key regulations
• Quality Management Systems (QMS): ISO 9001, ICH Q10, and cGMPs
• Regulatory Compliance: FDA, EMA, and MHRA regulations
• Pharmaceutical Quality Assurance: Quality planning, assurance, and control
• Regulatory Affairs Management: Product registration, variations, and renewals
• Pharmacovigilance: Drug safety monitoring, reporting, and risk management
• Clinical Trials Regulation: ICH GCP, GMP, and regulatory requirements
• Labeling, Packaging, and Artwork Control: Regulations, guidelines, and best practices
• Quality Risk Management: ICH Q9 and integrated risk management approach
Career Path
Entry Requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course Status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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