WORKSHOP ON CSV, DATA INTEGRITY AND 21 CFR PART 11 2017 - Seminar on Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5

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Category pharmaceutical; data integrity; CSV; FDA; 21 CFR; annex 11; glp; validation; Electronic Signatures; Warning Letters; 483s; ALCOA

Deadline: April 20, 2017 | Date: April 24, 2017-April 25, 2017

Venue/Country: Mumbai, India

Updated: 2017-02-14 00:18:57 (GMT+9)

Call For Papers - CFP

The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations.

Areas Covered:

Role of FDA

Computer Systems Validation Points

Why Validation?

Benefits of Validation

GAMP 5

21 CFR Part 11 Compliance

Annex 11

Data Integrity

Related Warning Letter Points

Computer Systems Validation Deliverables

Risk Assessment ….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

Medical Device Companies

Biotech Companies

Contract Laboratories

Clinical Research Organisations

Suppliers and Service Providers of Instruments and Computer Systems

Every Company that needs to comply with FDA Regulations