Using Microsoft Excel to Ensure Accurate Analysis, Monitoring and Training to be within required FDA Compliance - Profitability

Duration: 90 Minutes
This webinar will give attendees a broader perspective of how to use Microsoft Excel program and how this system has proven to be very successful in gaining FDA approval when the field inspectors come in to do their job. This ensures that the facility is operating in a way that is very reliable and consistent in doing what is needed to minimize patient risk. Microsoft Excel can be used in a multitude of ways for a vast majority of the operations within the facility to prevent data modifications. It is also a tool that provides the inspector to get the objective evidence that this facility maintains the high quality standards to avoid product and procedural errors.
Excel Training
Instructor: Jerry Dalfors
Product ID: 501365
Objectives of the Presentation
  • 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 is known to be the most effective means of doing the continuous statistical monitoring of every step in the product process and how easily this can be used by on-line operators
  • How Microsoft Excel 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 process like sterilization, lyophilization and several other process activities that need chamber monitoring for more than just temperature (HPD and TD). 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)
Why Should you Attend
There are many applications of Microsoft Excel which a majority of the industry in the typical Pharmaceutical, Medical Device and Solid Dosage companies are not aware of. Excel helps companies to enhance the operations to be consistent and reliable and to demonstrate it accurately. It also proves what 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 would you showcase that you are easily meeting all the requirements established by the applicable regulatory guidelines? This program will 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.

Who can Benefit
  • Manufacturing Engineering
  • Quality Control Professionals
  • Quality Assurance
  • Regulatory affairs personal
  • Analysts and technicians
  • Auditors
  • Project Managers
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects
  • Technical Operations and Validation Professionals
Topic Background
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 uses 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.
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How it works
Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
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