Revised Schedule M: Qualification & Validation

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About Course

The Revised Schedule M has introduced stricter and more structured expectations around Qualification and Validation in pharmaceutical manufacturing. This course is tailored to help professionals involved in quality assurance, engineering, validation, and production align their processes with the latest CDSCO requirements and GMP best practices.

Participants will gain practical insights into how to design and execute a complete qualification lifecycle—including DQ, IQ, OQ, and PQ—for equipment, utilities, facilities, and systems. The session also covers process validation, cleaning validation, and computer system validation, ensuring a holistic and compliant approach to delivering consistent product quality.

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Course Content

1. Revised Schedule M: Qualification & Validation

  • 1.1 Introduction
    01:56

2. Keynote Address by Chief Guest

3. Qualification & Validation

4. Panel Discussion and Open Q & A

5. Session Document(s) for Reading Purpose

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