Information Technology
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3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could... -
4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Electronic record/electronic signature (ER/ES) capabilities are extremely important and should be built into FDA-regulated computer systems to meets compliance with 21 CFR Part 11. This webinar will help you to strategize the development of a company philosophy and approach,... -
4-Hour Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
Computer systems used in conducting clinical trials must be evaluated to determine the level of compliance, established on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer... -
4-Hour Virtual Seminar on Project Management for Non-Project Managers
It is not possible to present a complete treatment of project management in the span of 3-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of... -
4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs
Computer system validation (CSV) 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 FDA has been regulating CSV for more than 30 years now.... -
4-Hour Virtual Seminar on Write SOP’s and Work Instructions that Really Work
This seminar will discuss how to transform your regulatory documentation process into a profit center, an operational force multiplier in how you run your business and the functions comprising it. Writing Standard Operating Procedures and Work Instructions is technical... -
4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could... -
6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices... -
6-Hour Virtual Seminar on Project Management for Non-Project Managers
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. It... -
Achieve Greater Productivity With Outlook Contacts, Calendar & Tasks
For most people, Outlook is a way of managing their mailbox however that is only part of what Outlook is capable of. In addition to being the world’s most popular email client, Outlook is also your calendar, your to-do... -
Artificial Intelligence in Pharmaceutical GMP Operations – Case Studies
This latest webinar will showcase possibilities with some case study examples of what can be done. The case study for manufacturing, maintenance, instrumentation, Quality assurance and regulatory assurance functions will be discussed. It is a must attend webinar to... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Automation Techniques for Your Excel-based Financial Statements
Excel wiz – Mr. Ringstrom, through this 90 minutes webinar will guide us on how to create dynamic financial reports on a single worksheet for any month in the financial year. Currently, if you are building worksheets for individual months,... -
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Avoid Reporting Cybersecurity Updates and Patches to the FDA
Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that... -
Bad Standard Operating Procedures (SOPs) – Bad Training: Garbage In, Garbage Out
Attend this webinar to improve the writing of both SOPs and training materials for more effective training and reduction of errors. Define the parameters of an effective SOP How your foundation keeps subsequent steps from going awry-preventing “garbage in”...
