Course Description

Proper Batch Record Review for Compliance and Effectiveness

Online On Demand

Course Offering 1905902OL2752A
Course ID 2752

In-Person Course

Who Should Attend?
This online training is designed for professionals in the Pharmaceutical, Medical Device and other life science industries. It will be especially valuable to the personnel and management, including senior management, in these areas:
  • Quality Control
  • Manufacturing
  • Regulatory Affairs
  • Quality Assurance

Course Description
In this 90-minute accredited training, we will discuss effective batch record review. 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.

Course Director
Danielle DeLucy, MS; Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, MS, is currently the owner of ASA Training & Quality Consulting, LLC, an Independent Consultant Agency 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 18 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 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, Ms. DeLucy assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.