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Webinar Search Results : 18 Upcoming webinars found.
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.
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.
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.
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. 
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.
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.
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.
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. 
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.
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. 
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:
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.
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.
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.
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.
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.
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.
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). -
Recorded
View Anytime
Duration:90 MinutesPrice: $190.00by: 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.
-
Recorded
View Anytime
Duration:90 MinutesPrice: $190.00by: 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.
-
Recorded
View Anytime
Duration:3 HoursPrice: $340.00by: 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.
-
Recorded
View Anytime
Duration:60 MinutesPrice: $190.00by: Michael Abitz
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
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Recorded
View Anytime
Duration:90 MinutesPrice: $190.00by: Robert J. Russell
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
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Recorded
View Anytime
Duration:60 MinutesPrice: $190.00by: Michael Abitz
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
-
Recorded
View Anytime
Duration:90 MinutesPrice: $190.00by: 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.
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Recorded
View Anytime
Duration:90 MinutesPrice: $190.00by: 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.
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Recorded
View Anytime
Duration:90 MinutesPrice: $190.00by: Angela Bazigos
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
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. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
