Efficient and Effective Batch Record Reviews to Improve your Process Capabilities | May 10, 2016 10:00 AM - May 10, 2016 1:00 PM | Automation.com

Efficient and Effective Batch Record Reviews to Improve your Process Capabilities

Event Summary

DATE:
May 10, 2016
START DATE/TIME:
May 10, 2016 10:00 AM
END DATE/TIME:
May 10, 2016 1:00 PM
TIME ZONE:
(GMT -8:00) Pacific Time (US & Canada)
EVENT TYPE:
Webinar
HOST:
Online Compliance Panel
PHONE:
15108575896
EMAIL:
[email protected]
WEBSITE:
Click here to Visit

Description

Description
Upon completion of this session, attendees will learn the fundamentals for reviewing batch records in a pharmaceutical environment. They will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and they will learn how to react to discrepancies found in these records.

Objectives of the Presentation
Recognize regulatory requirements for batch records and batch record review
Discover the essentials of batch record reviewer qualifications and training
Establish a working relationship between production and quality reviewers
What to do when a batch fails to meet specifications (discrepancies and deviations)

Why Should you Attend
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.

Areas Covered
Regulatory requirements for batch record review
What to look for while reviewing batch records, i.e., good documentation practices, compliance to critical quality attributes and critical processing parameters
Skills and responsibilities of an effective batch record reviewer
Tools for effective batch record review
Ensuring Production and Quality reviewers coincide with their reviews
Extensive Training plan for batch record reviewers and when can they be considered “qualified” to review a record

Who can Benefit
Quality Assurance batch record reviewers
Production personnel and Production Managers who review batch records

Note: Use Promo code VBTPK and get 10% off on registration (Valid till May 31st 2016)

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Related Portals:
Process Automation

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