Quality Attributes for Sterile Packaged Waters

On-Demand Webinar

Course Descriptions

Quality Attributes for Sterile Packaged Waters

Originally recorded lon October 11, 2011, this recording explains 1) compendial proposed requirements for Sterile Water for Injection, Sterile Water for Irrigation, Sterile Water for Inhalation and Sterile Purified Water and 2) examines the support information used to set the proposed criteria in sterile packaged waters for: 1) replacement of the Oxidizable Substances test with chapter Total Organic Carbon <643>, and b) proposed Water Conductivity <645> levels, based on nominal volume of the container.

 

Category: 
Noncomplex Drug Substances, Products, and Excipients
Objectives: 

Understand the proposed requirements for sterile packaged water monographs Understand the rationale behind proposed criteria for chemical testing Know the current and future sterile packaged waters iniatives

Who Should Participate: 

Regulatory personnel and authorities; Project managers; Operations managers; QA & QC staff

Dates Offered

There are no other scheduled times for this course.

Registration Information

Regular Price Information: 

$150.00