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Speaker Profile
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley- Friday, August 17, 2018
- 09:00 AM PDT | 12:00 PM EDT,
- 3 Hours
- ¤290.00
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
- Monday, August 20, 2018
- 10:00 AM PDT | 01:00 PM EDT,
- 90 Minutes
- ¤150.00
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.
- Tuesday, August 21, 2018
- 09:00 AM PDT | 12:00 PM EDT,
- 3 Hours
- ¤290.00
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms.It will present the specific guidance FDA inspectors receive for each of the regulations.
- Thursday, August 23, 2018
- 10:00 AM PDT | 01:00 PM EDT,
- 90 Minutes
- ¤150.00
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
- Recorded
- View Anytime
- 90 Minutes
- ¤390.00
In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations.
- Recorded
- View Anytime
- 90 Minutes
- ¤157.00
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
- Recorded
- View Anytime
- 90 Minutes
- ¤163.00
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
- Recorded
- View Anytime
- 90 Minutes
- ¤167.00
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
