Webinar Search Results : 18 Upcoming webinars found.
Carolyn Troiano Friday, October 18, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Carolyn Troiano
3-Hour Virtual Seminar on Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.

Angela Bazigos Friday, October 18, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Angela Bazigos Thursday, October 24, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Bootcamp on How the FDA are Trained for Medical Device Inspections
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.

Carolyn Troiano Thursday, October 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
Good Documentation Practices to Support FDA Computer System Validation
As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.

Joy McElroy Monday, October 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Joy McElroy
GLPs: How are they Associated with GMPs and SOPs
Good Laboratory Practices (GLPs), CFR part 58 is a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

Joy McElroy Tuesday, October 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Joy McElroy
Writing Validation Master Plans; Best Practices for Writing a Compliant Document
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs.

Angela Bazigos Wednesday, October 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions
The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Angela Bazigos Friday, November 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.

David Nettleton Monday, November 4, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: $150.00
by: David Nettleton
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Carolyn Troiano Wednesday, November 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Allecia Harley Thursday, November 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: Allecia Harley
Does Having a Clinical Trial Management System Actually Decrease Study Start-Up Times?
Clinical Trial Management Systems have been sold as the answer to a number of challenges:

David Nettleton Thursday, November 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:2 Hours
Price: $190.00
by: David Nettleton
2-Hour Virtual Seminar on The 6 Most Common Problems in FDA Software Validation and Verification
This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

William D Fox Friday, November 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: William D Fox
GxP Quality Management System (QMS): Moving from Compliance to Quality
There are those of us who think that the psychology of man, each and together, has more impact on markets, business, services, construction, and the entire fabric of an economy than all the more measurable statistical indices.- Malcom S. Forbes.

Angela Bazigos Friday, November 15, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.

Steven Wachs Monday, November 18, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: $150.00
by: Steven Wachs
Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

Carolyn Troiano Monday, November 18, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
FDA's New Draft Guidance on Software and Device Changes and the 510(k)
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.

William D Fox Tuesday, December 3, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: William D Fox
The GxP Audit Report and The Savannah Brain
"It's not what you say but how you say it." - Every Parent The written audit report is arguably the most important phase of an audit. It serves as a record of GxP compliance, a list of risk appraised audit findings and a value adding tool which actuates assessment, relates assurance and promotes action.

David Nettleton Wednesday, December 4, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: David Nettleton
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

Payment Methods

Contact Us

NetZealous LLC,
39658 Mission Boulevard, Fremont,
CA 94539, USA.

Information

  Refund Policy
  +1-800-447-9407
  Fax: 302 288 6884
  support@compliance4All.com