Regulatory Requirements for Batch Record Review

Overview:

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.

Areas Covered in the Session:

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

Who Will Benefit:

Quality Assurance Batch Record Reviewers

Production Personnel

Production Managers who Review Batch Records

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker Profile:

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.