Pharmaceutical Quality Control
Ignite your career with our Pharmaceutical Quality Control course! Become the gatekeeper of pharmaceutical perfection, mastering quality standards and compliance. Launch your rewarding career in quality control today. What do you learn in the Pharmaceutical Quality Control Course? Strict Adherence …
Ignite your career with our Pharmaceutical Quality Control course! Become the gatekeeper of pharmaceutical perfection, mastering quality standards and compliance. Launch your rewarding career in quality control today.
What do you learn in the Pharmaceutical Quality Control Course?
- Strict Adherence to Health and Hygiene Protocols
- Rigorous Compliance with Safety and Security Procedures
- Proficient Handling of Emergency Procedures
- Pre-analysis Checks
- Laboratory Investigations and Analysis Techniques
- Implementation of Environment Sustainability Practices
- Reporting and Recording
- Documentation Adherence according to GDP, GLP, and GMP Standards
- Ensuring Data Integrity
- Effective Coordination with Managers, Team Members, Cross-functional Teams, and Auditors
- Demonstrating Sensitivity to All Genders and Individuals with Disabilities
- Routine Inspection of Laboratory Instruments
- Identifying Non-conformities
- Labeling Procedures
- High-Performance Liquid Chromatography (HPLC) Analysis
- Ultraviolet-visible Spectroscopy for QC Analysis
Who should take the Pharmaceutical Quality Control Course?
- Aspiring Quality Control Analysts
- Pharmaceutical Manufacturing Professionals
- Quality Assurance Officers
- Regulatory Affairs Specialists
- Professionals in the Pharmaceutical Industry
- Graduates in Pharmacy and Related Fields
About this Certificate Course
The Pharmaceutical Quality Control Course goes beyond the basics to provide a comprehensive understanding of health and safety protocols, emergency procedures, and sensitivity towards diverse groups. It emphasizes the importance of environmental sustainability and the adoption of sustainable practices. Through rigorous reporting, documentation, and coordination with teams and auditors, students develop the skills required for quality control in the pharmaceutical sector.Â
Moreover, hands-on experience in utilizing sophisticated analytical tools such as High-Performance Liquid Chromatography (HPLC) and Ultraviolet-visible Spectroscopy enhances their analytical capabilities. This program prepares graduates to excel in ensuring pharmaceutical product quality and regulatory compliance.
Course Outline
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Why you should take the Pharmaceutical Quality Control Course?
Learning the Pharmaceutical Quality Control Course is paramount for several reasons. It equips you with the expertise needed to maintain pharmaceutical product quality, adhere to regulatory compliance, and ensure the safety of consumers. The course covers health and safety protocols, adherence to quality standards, data integrity, and environmental sustainability practices. By mastering these skills, you become a valuable asset to pharmaceutical companies, opening doors to diverse career opportunities in quality control, safety assurance, and regulatory compliance.
Career Opportunities
Curriculum
- 5 Sections
- 28 Lessons
- 16 Weeks
- UNIT-I8
- 1.1Overview of Life Sciences industry in Indian and global context.
- 1.2Industrial Practices like Standard Operating Procedure (SOP), GMP, GLP, 21CFR and ALCOA Plus guidelines relevant to Analyst/Chemist-Quality Control.
- 1.3Impact of Non-compliance on the quality of the product.
- 1.4Discuss workplace hazards and their reporting in the laboratory and manufacturing facility as per 5S system in the life sciences sector.
- 1.5Explain different types of breaches in the environment, health, safety and security.
- 1.6Effectively communicate and collaborate with manager and colleagues for multiple scenarios.
- 1.7Discuss how to respond to auditors with integrity.
- 1.8Discuss the rules laid by the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act and the provided penalties for violation.
- UNIT-II4
- 2.1Pipetting and Micro pipetting techniques.
- 2.2Properties and Safe handling of standards, solvents, reagents, hazardous chemicals and their storage as per Hazard Classification.
- 2.3Steps to prepare and standardize volumetric solutions and test solutions.
- 2.4Types of tests performed in quality control lab in various formulations, Active Pharmaceutical Ingredient (API) and packaging material.
- UNIT-III4
- 3.1Various statistical concepts used in laboratory investigation and Pre-analysis.
- 3.2Calibration and accuracy test for lab instruments.
- 3.3Standardization, validation related documentation and e-Lab Note Book (eLNB) for documenting experiments and analysis reports.
- 3.4Concepts of Corrective Action and Preventive Action (CAPA) and change control.
- UNIT-IV7
- 4.1Properties of different chemicals, reagents and reference standards and working standards used for HPLC analysis.
- 4.2Safety measures to be taken while operating the HPLC instrument.
- 4.3Method Development & Method Validation Procedures for HPLC
- 4.4Sample preparation Procedure for HPLC analysis in light of stability and storage requirement.
- 4.5Analytical calculations required in a HPLC analysis
- 4.6Methods of recording and analysis of HPLC chromatogram.
- 4.7Concepts of HPLC data deviations in case of deviations in the results.
- UNIT-V5
- 5.1Properties of different chemicals, reagents and standard solutions used for Ultraviolet (UV) – visible spectroscopy analysis.
- 5.2Recall the safety measure to be taken while handling Ultraviolet (UV) – visible spectroscopy.
- 5.3Discuss the procedures of sample preparation for Ultraviolet (UV) – visible spectroscopy analysis.
- 5.4Troubleshooting and Calibrate Ultraviolet (UV) – visible spectroscopy machine.
- 5.5Explain methods of recording and analysis of UV- visible spectroscopy test results.
