Past event: Virtual Seminar on Batch Record Review and Product Release
6-Hour Virtual Seminar
This event has already taken place.
This page shows historical information on the Virtual Seminar on Batch Record Review and Product Release, held on May 18, 2021 in Online Event,
Your Computer
The new edition of this event will be held on January 21, 2021
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.
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 Will Benefit
Quality Assurance batch record reviewers
Production personnel and Production Managers who review batch records
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 17 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.
The full agenda is not yet available for this event. Follow this event to receive an alert when the agenda becomes available.
08:00 AM PDT | 11:00 AM EDT
I. 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
II. Methods for Batch Record Review
Defining the Review process
Match Record SOP development
Roles and responsibilities of reviewers both Quality and Operations
Effective review practices and tools to identify discrepancies
III. Methods for Data Review and Actions taken for Deviations
Review of Analytical Data
Out-of Specification test results and deviations
IV. Case Study - Review of a Mock Batch Production Record
Venue
The venue is not yet available for this event. Follow this event to be informed when the venue is available and stay informed on other changes.