Effective Batch Record Review
Product Id : FDA137Instructor : Danielle DeLucy
Jun 27, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
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Description
Overview
A batch record review is a complicated and often lengthy process. However, a strong review system is essential so all critical processing parameters are properly documented. Learn the fundamentals of batch record reviewing and its necessary elements, in this webinar.
Regulatory agencies often require firms to have written procedures to document production and process controls. These written procedures are known as batch records, and they in turn require a batch record review process, to demonstrate compliance. Reviewing batch records can be tough work, especially if you do not know what to do at each step. During this webinar, our expert speaker will walk you through the subject of batch record reviews, providing crucial information and equipping you with tools which will help you perform your duties better.
You will learn the regulatory requirements for batch record review, and what to look for during a batch record review – good documentation practices, compliance to critical quality attributes and critical processing parameters, etc. You will also learn about a training plan which batch record reviewers must undergo, before they are considered qualified for the job.
Other topics of discussion include: what to do when a batch does not meet specifications (i.e., when it has discrepancies and deviations), how to establish a strong working relationship between production and quality reviewers, how to ensure that production and quality reviewers coincide with their reviews, and more.
Training Highlights:
- Learn the fundamentals of batch record review in a pharmaceutical environment
- Learn the regulatory requirements for batch records and for reviewing them
- Learn what to look for while reviewing batch records
- Learn the essential skills and responsibilities of an effective reviewer
- Gain useful tools for reviewing batch records
- Learn how to ensure that Production and Quality reviewers coincide with their reviews
- Learn what steps to take when a batch does not meet specifications
- Learn about training required to become a qualified batch reviewer
The following people will benefit from, and should therefore attend, this webinar:
- Quality Assurance and Batch Record Reviewers
- Production Personnel
- Production Managers
- Compliance Auditors
- Manufacturing Management & Scientist
- Other professionals who review batch records
Speaker Profile:
Danielle DeLucy,is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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