2-Hour Virtual Seminar on A Practical and Compliance view on Deviations in Pharmaceuticals

Overview:

There are lot of requirements related to the deviations in pharmaceuticals. But are we really complying to these requirements? Some of the requirements are as below;

Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented.

Written procedures should be established and followed for investigating critical deviations or the failure of a batch of intermediate or API to meet specifications.

Why should you Attend:

The learning objectives are firstly understand the deviation requirements in Pharmaceutical organisations

The attendees will get the practical and scientific insight about the deviation process in pharmaceuticals.

The benefits are, 

• The person’s understanding about deviations with risk based approach will be clear
• The personnel will develop the compliance approach rather than just following the existing deviation systems
• The deviation awareness will increase in the company

Areas Covered in the Session:

• Brief introduction of the concept
• Guideline expectations about deviations- EU,FDA, ICH, ANVISA, ISO etc
• Detailed understanding about deviations
• Scientific way for categorization of deviations -Simplified risk assessment tool in line with WHO recommendations
• Categorization strategy for repeat deviations
• Effective writing of deviations
• Trending - Points need to consider
• Q&A session

Who Will Benefit:

• Quality Assurance
• Quality Control
• Pharmaceutical IT compliance
• Global QA
• corporate QA and QC
• IT Personnel working or related to Pharma IT Support