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GMP for Quality Control Laboratories and FDA Audit Preparation

In-depth understanding of GMP and Lab compliance.

You will gather a thorough awareness of latest trends and updates with respect to USFDA, EU, WHO and PIC/S (Pharmaceutical Inspection Co-operation Scheme) and Indian GLP Schedule L1 compliance and guideline requirements. This course will also provide examples to develop inspection ready documentation.

On completion of this course, the participants shall be well versed with the global Quality control laboratory compliance requirements, inspection trends as well as strategies and best practices for maintaining regulatory compliant GLP standards to ensure consistent Quality Attributes and bench marking Quality Metrics in the Pharmaceutical Quality Control Laboratories.

Practical examples and interactive exercises will be dispersed into and between the presentations. Here the experts will discuss case studies and create a platform platform to resolve QC laboratories' day-to-day issues like Documentations, Investigations (OOS, OOT, OOC) and validation compliance checklists to ensure you are well prepared for your next audit.

LEARNING OBJECTIVES :

  • FDA, EU, WHO, PIC/S, India GLP Regulations
  • 21 CFR part 11 and EU Annex 11
  • FDA 483s and Warning Letters Observations
  • Validation Master Plan
  • SOPs and Best Practices
  • Equipment Calibration and Qualification
  • Systems Validation
  • Analytical Method Validation
  • OOS, OOT and OOC
  • Laboratory Data integrity
  • FDA Audit Preparation

WHO MUST ATTEND

- Quality Control
- Quality Assurance
- Research and Development
- Manufacturing
- Regulatory Compliance
- Validation
- Production
- Technology Transfer
- Laboratory
- Documentation
- Training departments

When

22 Feb 2018 @ 09:00 am

23 Feb 2018 @ 06:00 pm

Duration: 1 days, 9 hours

Where

Mercure KCP

Mercure KCP, Banjara Hills Rd

560001 Hyderabad

India

Organised by

Compliance Trainings

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