Efficient and Effective Batch Record Reviews to Improve your Process Capabilities

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90mins Live Webinar

"Hear By Danielle DeLucy, MS, 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"

Good documentation practices

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 will Benefit

•          Quality Assurance batch record reviewers
•          Production personnel and Production Managers who review batch records
•          Compliance Auditors
•          Manufacturing Management & Scientist
•          Other professionals who review batch records

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Danielle DeLucy

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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