Puritan Enviromax and ESK for Surface Sampling

21 CFR Part 11 and Risk Assessment, Avoid Warning Letters and Reduce Costs - Hyderabad, India

2017, August 3 - 4

Clinical, Other, Pharmaceutical » Training, Seminar

This 2-day Seminar on 21 CFR Part 11 and Risk Assessment will help you get completely familiar with the FDA – compliant implementation of 21 CFR Part 11 requirements applicable to the regulated industry.

Our instructor - Mr. KR Vaghela, will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation.

Areas covered:
21 CFR Part 11 Compliance
Key Requirements of Part 11 & Annex 11
Learning from Recent Warning Letters
Computer System Validation
Achieving Data Integrity
Meeting Data Integrity Regulations
Risk Assessment
Risk Based Validation
VMP & Design Specifications
Case Studies and more

A must attend seminar for professionals in:
Pharmaceutical Development Companies
Quality Control Laboratories Companies
Quality Departments of API Manufacturers
Quality Departments of Finished Product Manufacturers
Contract Laboratories
Clinical Research Organisations

LOCATION 2 - 7th & 8th August 2017 – Bangalore, India

LOCATION 3 - 10th & 11th August 2017 – Goa, India

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Compliance Trainings
Phone: 416-915-4458
Email: support@compliancetrainings.com
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