Batch Record Review and Product Release Virtual Seminar: Regulatory Requirements for GMP Documents - Batch Records and Beyond

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Nov 01, 2023, 12:00 ET

DUBLIN, Nov. 1, 2023 /PRNewswire/ -- The "4-Hour Virtual Seminar on Batch Record Review and Product Release" seminar has been added to ResearchAndMarkets.com's offering.

In the realm of pharmaceuticals, biologics, and medical devices, Regulatory Agencies mandate the presence of meticulously crafted written procedures, known as batch records, to document production and process controls. These critical records stand as a testament to compliance, providing a comprehensive account of all essential processing parameters tied to the manufacturing process.

In this seminar, you will discover how the Batch Record process is vital in properly documenting and validating the entire production and manufacturing journey, guaranteeing adherence to strict regulatory standards. Through in-depth analysis, it will explore each indispensable element of the batch record review process, empowering you to excel in regulatory compliance and elevate your industry prowess.

Learning Objectives:

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)

Key Topics Covered:

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

For more information about this webinar visit https://www.researchandmarkets.com/r/ffcb7s

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SOURCE Research and Markets