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Batch Record 2022 - 4-Hour Virtual Seminar on Batch Record Review and Product Release



VenueOnline, Online Online

KeywordsCompliance; FDA; Batch Records


Topics/Call fo Papers

4-Hour Virtual Seminar on Batch Record Review and Product Release
Product Id : FDB3282
Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Medical Devices, Quality, Virtual Seminars
Presenter : Danielle DeLucy
Scheduled On : March 03 2022 10:00 am
US/Canada (Eastern Time - ET)
Duration : 4 Hours
Please click on the following link to Register :
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 seminar will analyze each of these necessary elements of the batch record review process.
Why You Should Attend:
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)
Who Should Attend:
Quality Assurance Departments
Manufacturing Departments
Production Departments
Validation Departments
Documentation Departments
All professionals who review batch records
Lecture 1: Regulatory Requirements for GMP Documents – Batch Records and Beyond
Review Good documentation requirements for batch records
Types of Regulated documents and relative importance
Master Batch Record Templates – Control and Issuance
Manufacturing Records – In process and final product
Specifications – Quality Review
Investigations – Deviation and Out of Specifications
Change Control Process
Lecture 2: Methods for Batch Record Review
Defining the Review process
Batch Record SOP development
Roles and responsibilities of reviewers both Quality and Operations
Effective review practices and tools to identify discrepancies
Lecture 3: Methods for Data Review and Actions taken for Deviations
Review of Analytical Data
Out-of Specification test results and deviations
Lecture 4: Case Study – Review of a Mock Batch Production Record
Danielle DeLucy
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.
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.

Last modified: 2022-02-16 01:06:37