Cleanroom and Aseptic Area in the Pharmaceutical Industry
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LevelAll Levels
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Total Enrolled91
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Duration17 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
Description
Welcome to Pharmastate Academy’s comprehensive course on “Validation, Calibration & Qualification.” Explore the vital role of Validation, Calibration, and Qualification in pharmaceutical production and quality assurance. Objectives include understanding validation principles, exploring calibration intricacies, and mastering equipment, facility, and process qualification for regulatory compliance.
Delve into validation processes, studying life cycles, protocols, reports, and various types. Validation stages, from design to performance, are explained, emphasizing the importance of systematic approaches. Validation protocols and reports, crucial for regulatory transparency, are detailed.
Calibration’s significance is highlighted, distinguishing it from validation. Learn about instruments requiring calibration, procedures, and documentation. Move on to equipment and facility qualification, including IQ, OQ, and PQ. Facility qualification covers cleanrooms and HVAC systems.
Real-world case studies showcase successful validations, calibrations, and qualifications. Explore challenges faced during production changes and method transfers, emphasizing the importance of change control and robust protocols.
Join us to gain practical skills, apply knowledge through case studies, and ensure excellence in pharmaceutical processes. Elevate your career with Pharmastate Academy’s Validation, Calibration & Qualification course!
What I will learn?
- Validation Processes - Life Cycles, Protocols, Reports and Types of Validation.
- Calibration - Importance of Calibration, Difference between Validation and Calibration, Procedure and Documentation.
- Qualification - Equipment and Facility Qualification.
- Control and Management of documents.
- Real-life case studies related to Validation Calibration and Qualification.
Course Curriculum
1. Cleanroom & Aseptic Area in the Pharmaceutical Industry
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1.1 Objectives
02:28 -
Quiz: Introduction
2. Types of Cleanroom
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2.1 Types of Cleanroom
02:56 -
Quiz: Types of Cleanrooms
3. Design and Construction of Cleanrooms
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3.1 Design and Construction of Cleanrooms
02:19 -
Quiz: Design and Construction of Cleanrooms
4. Aseptic Area & Sterile Processing
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4.1 Aseptic Area & Sterile Processing
02:44 -
Quiz: Aseptic Area and Sterile Processing
5. Cleanroom Protocols & Procedures
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5.1 Cleanroom Protocols & Procedures
03:01 -
Quiz: Cleanroom Protocols and Procedures.
6. Case Studies & Examples
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6.1 Case Studies & Examples
03:02 -
Quiz: Case studies and Examples
7. Final Assessment
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Quiz
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Course Ratings & Reviews
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LevelAll Levels
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Total Enrolled91
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Duration17 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
Material Includes
- 5 Learning Videos
- 6 Quizzes
- Course Certificate
Target Audience
- Pharma professionals from manufacturing.
- QA, QC, and Regulatory Affairs.
- Students pursuing D.Pharm, B.Pharm.
- M.Pharm, Ph.D., & Pharm D.