Webinar Search Results : 21 Upcoming webinars found.
Angela Bazigos Tuesday, January 8, 2019
10:00 AM PST | 01:00 PM EST
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 learn 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.

David Nettleton Wednesday, January 9, 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).

Teri C. Soli Tuesday, January 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Teri C. Soli
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Michael Abitz Tuesday, January 15, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Michael Abitz
Root Cause Failure Analysis Closed Loop Corrective Action
Root Cause Failure Analysis 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.

Angela Bazigos Wednesday, January 16, 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
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

Angela Bazigos Wednesday, January 23, 2019
10:00 AM PST | 01:00 PM EST
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.

Dr. Afsaneh Motamed Khorasani Thursday, January 24, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation and Record Keeping Best Practices (FDA & EMA)
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Dr. Shuguang Huang Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:2 Hours
Price: ¤190.00
by: Dr. Shuguang Huang
2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective
Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:

Eyal Lerner Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Eyal Lerner
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Angela Bazigos Thursday, January 31, 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 Incident Management and CAPA for GxP Computerized Systems Operations
This Webinar specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

David Nettleton Thursday, January 31, 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.

Michael Abitz Tuesday, February 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: 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.

Angela Bazigos Wednesday, February 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Lean Document Control for Manufacturing in Life Sciences
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Dr. Afsaneh Motamed Khorasani Thursday, February 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation Guideline (Chapter 1029 USP)
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials).

Teri C. Soli Tuesday, February 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Teri C. Soli
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

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
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.

David Nettleton Tuesday, February 19, 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).

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.

John N. Zorich Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

David Nettleton Tuesday, February 26, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
How to validate software for SaaS-Cloud-Local Hosting
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based approach to COTS software validation minimizes documentation and ensures efficient implementation of new and upgraded computer systems.

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.

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