Process Validation By Raman Mehta

USFDA release the guidance documents on Process Validation titled “Process Validation: General Principles and Practices” in January 2011. However the approach laid down in this document is still being not adopted completely by the industries till date. The concept laid down was to transfer the complete process optimization activities to R & D from manufacturing instead of struggling during the Production phase. This would lead to cost saving and reduces the chances of failure of the product when it has been transferred to the manufacturing phase.

Raman Mehta

Fate of your decision lies in data accuracy. When you take a decision, it may be a good decision or a bad one. However the same is completely dependent on the accuracy of the data being evaluated by you, same applies to the Management Information System also.
The decision of the management may go wrong in case there is inaccurate data and inadequate Management Information System.
These are the two sides of the same coin, however, they are taught to us in different way.

Smoke Study by Raman Mehta

Air Flow Pattern or Smoke studies have been one of the interesting areas for the Inspectorates, nowadays. There is very low amount of attentions being paid by the organization when we are designing the smoke pattern protocols and reviewing the videotapes. Sometime situations are there companies do not understand how to review the Air Flow Pattern or Smoke study recordings. This article shall explain everything on the topic and bring the clarity on each segment of Air Flow Pattern. It will make Smoke Study so simple.

Data Integrity by Raman Mehta

Pharmaceutical and Biopharmaceutical industries must develop the strategies to eliminate the Data Integrity from their Organizations. However, the biggest problem is that the Organization are bounded with multiple myths which stops them to come out of the issues pertaining to data Integrity. Five biggest myths which are hindering in the […]

Employee Engagement by Raman Mehta

Performance & Productivity are the two common parameters that are frequently measured within the organization. However, it is important to understand that both the parameters are highly influenced by the engagement of the employee (in terms of their feelings & emotions) with the organization. Research proves that engaged employees are better performers as compared to the disengaged employees. Below mentioned 7 strategies will give you insight how the employee engagement of the organization can be enhanced.

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