Regulatory Requirements for Batch Record Review

Added by Compliance4all on 2018-10-08

Conference Dates:

Start Date Start Date: 2018-12-03

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email: [email protected]
Address Address: 161 Mission Falls Lane, Suite 216,, Fremont, California, 94539, United States
Phone Tel: 18004479407
Phone Fax: 302-288-6884

Conference Description:

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

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.

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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
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