Description:-

This program  is going to be presented to give the attendees a better or broader perspective of how to use this program from a more comprehensive understanding based on how this system has been proven to be very successful in gaining FDA approval when the field inspectors have come in to do their job to ensure this facility is operating in a way that is very reliable and consistent in doing what is needed to minimize patient risk.  By using Microsoft Excel in a multitude of ways for a vast majority of the operations within the facility using proper prevention of data modifications as well as being a tool that provides the inspector to be able to get the objective evidence that this facility is seriously quality oriented to avoid product and procedural errors.

Background of the Topic:

Microsoft Excel is one of the best-computerized tools to be used to provide the needed objective evidence for a vast majority of the products being produced that are under the regulations of the FDA, EPA, DEA, etc.  However, because it is a computerized system the data could be modified to make the data look better instead of being “actually true” so the typical computerized tracking and protection have to be applied.  However, Excel can be used for a tremendous other use to help your company become more likely to avoid receiving a 483, warning letter or consent decree by ensuring each aspect of the required Quality Systems established at each of your facilities are being conducted in compliance with FDA regulations.

Why should you attend?

There are a number of different needs and related applications a majority of the industry is not aware of for using Microsoft Excel in the typical Pharmaceutical, Medical Device and Solid Dosage companies to enhance how well the operations are being demonstrated to be consistent and reliable including how we are proving we have been doing what is needed for the specific process as well as all the needed FDA compliance elements to minimize any concerns by the field inspectors.  How are you proving you are easily meeting all the requirements established by the applicable regulatory guidelines? That is what is going to help each attendee have a better comprehension of how to use the excel spreadsheet to help the company have less risk, better objective evidence and to be more profitable.

Areas Covered in the Session:

• Microsoft Excel can be used for a vast majority of helping and tracking company operations
• In processes where the in-process monitoring are needed to predict very accurately when that specific step in the process has reached the defined end point.
• To meet the current PV Guidelines, Microsoft Excel with being shown to be most effective means of doing the continuous statistical monitoring of every step in the production process and how easy this can be used by online operators and then finding immediate incidents
• How Microsoft Excel has been used and once the FDA came back in to inspect a serious warning letter or PDA serious issues has been used to get FDA immediate approval.
• During development and validation, how Microsoft Excel is being used to demonstrate the consistency within a chamber for processes like sterilization, lyophilization and several other process activities that need chamber monitoring for more than just temperature (HPD and TD).  The Z-score analysis is a good example.
• Techniques for using Microsoft Excel for the majority of Quality Systems requirements needed to help the internal staff as well as proving the company is performing the needed activities to prove the company is doing what is required to be in compliance with current regulations to minimize patient risk and make sure when incidents are being tracked properly prior to making changes (CAPA).  Too many companies are just opening a CAPA without the situation having been entered into the ITS (incident tracking system)

Who will benefit?

Anybody wanting to make their company more quality related and profitable.