Overview: This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components.
It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for documentation review. Additionally, the course will look at the creation of disposition packages for approval and rejection of materials, and cover changes in disposition status.
The course will not cover the disposition of raw materials, third party (CMO) manufacturing, or validation lots.
Why should you attend: The process for the disposition of product lots can be tedious and overwhelming. The requirements for intermediates, Active Pharmaceutical Ingredients (API), drug substances, medical devices, finished product, and even in-house manufactured components must meet certain specifications and/or regulatory requirements to ensure the identity, strength, quality and purity of the lot. The intent of this program is to define a process that helps to ensure that all lot dispositions are performed consistently and in compliance with sound quality management systems.
Areas Covered in the Session:
* Compilation of Completed Records
* Quality Technical Agreements
* QA review of production records
* Laboratory Testing Results
* Batch Production Record Review
* Critical Utilities and Environmental Monitoring Data
* Requirements for COA
* Communication
* Lot disposition
Who Will Benefit:
* Batch Release personnel
* Batch Record Reviewers
* Lot Records Compilers
* Site Quality Heads
It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for documentation review. Additionally, the course will look at the creation of disposition packages for approval and rejection of materials, and cover changes in disposition status.
The course will not cover the disposition of raw materials, third party (CMO) manufacturing, or validation lots.
Why should you attend: The process for the disposition of product lots can be tedious and overwhelming. The requirements for intermediates, Active Pharmaceutical Ingredients (API), drug substances, medical devices, finished product, and even in-house manufactured components must meet certain specifications and/or regulatory requirements to ensure the identity, strength, quality and purity of the lot. The intent of this program is to define a process that helps to ensure that all lot dispositions are performed consistently and in compliance with sound quality management systems.
Areas Covered in the Session:
* Compilation of Completed Records
* Quality Technical Agreements
* QA review of production records
* Laboratory Testing Results
* Batch Production Record Review
* Critical Utilities and Environmental Monitoring Data
* Requirements for COA
* Communication
* Lot disposition
Who Will Benefit:
* Batch Release personnel
* Batch Record Reviewers
* Lot Records Compilers
* Site Quality Heads
