Dec, 03

Regulatory Requirements for Batch Record Review

Monday, Dec, 03, 2018 From 09:00 AM to 12:00 PM

LOCATION
161 Mission Falls Ln #216, Fremont, CA 94539, USA

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* Note : This is a public Event.

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

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: support@compliance4All.com

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161 Mission Falls Ln #216, Fremont, CA 94539, USA

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2018-12-03 09:00:00 2018-12-07 12:00:00 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

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: support@compliance4All.com

161 Mission Falls Ln #216, Fremont, CA 94539, USA Netzealous LLC DBA - Compliance4All support@compliance4All.com
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