For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data...
By the end of January (technically February 1, 2016, because January 31, 2016, is a Sunday), you should have provided various types of information returns you’re your contractors, landlords, and other independent payment recipients need for their personal tax...
Are your spreadsheets lacking the integrity and resilience you wished for? This webinar presented by Excel expert David Ringstrom, CPA, will prove to be extremely insightful and helpful. We will take a deep dive into a variety of worksheet...
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The...
Upon completion of this session, you will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the...
This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. It details the requirements for Part 11 and Annex 11:...
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Pharmaceutical...
This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for...
Attendees will also receive an Excel spreadsheet with the d*2 factors that are required for the average and range method, and another with data for the worked examples. These appear in some references that are named in the handout,...
Power Pivot and Power Query are free addins for Excel, written by Microsoft (in fact in Excel 2016 and later Power Query is built into the application and not an addin at all). Power Pivot puts the “power” into...
In this empowering and insightful presentation, Excel expert David Ringstrom, CPA, teaches you the basics of creating and using Excel pivot tables. He will then take you beyond pivot table basics and shows you step-by-step how to manipulate pivot...
Payroll professionals might not be aware of the many features and functions available in Excel that can be used to improve the accuracy and efficiency of their payroll production. In this valuable webinar, Excel expert David Ringstrom, CPA, demonstrates...
Effective January 1, an estimated 10 million employees will pay more Social Security payroll taxes for the coming year due to an increase in the taxable minimum-up to $118,500 over the previous amount, $117,000. Employers should take steps now...
In this important webinar presented by Mark Schwartz, will explain the latest payroll tax updates coming for 2017, including updates on W-2s, healthcare reporting, and more. Ensuring payroll tax requirements are met for 2017 should be on every HR...
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation...
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11....
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