Webinar Search Results : 13 Upcoming webinars found.
Angela Bazigos Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest Thinking
Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

Angela Bazigos Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
European Data Protection Regulation - Latest
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

Angela Bazigos Wednesday, February 27, 2019
12:00 PM PST | 03:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Risk Based Service Management and Performance Monitoring for GxP Computerized Systems Operations
This Webinar specifically addresses the Service Management and Performance Monitoring of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

Angela Bazigos Monday, March 4, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.

Angela Bazigos Monday, March 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Angela Bazigos Thursday, March 14, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Quality Metrics - Latest Advances
This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee.

Angela Bazigos Thursday, March 21, 2019
12:00 PM PDT | 03:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
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.

Angela Bazigos Friday, March 29, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Boot Camp on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

Angela Bazigos Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Audit Trail Generation and Review
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.

Angela Bazigos Monday, April 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out Your Competition!
Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products' status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product's regulatory or marketing status in the U.S.

Angela Bazigos Wednesday, April 10, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

Angela Bazigos Friday, April 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Angela Bazigos Wednesday, April 17, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Good Clinical Practices for Successful FDA and International Regulatory Authority Inspections
This webinar will highlight the salient points of Good Clinical Practice and will enable the participants to understand how to implement GCP to achieve clinical trial best practices, best patient safety and/or successful FDA and international regulatory authority inspections.

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