Electronic Signatures Web-based Seminars

GxP Computer System Validation The investigators Point of View - Webinar By GlobalCompliancePanel Overview: The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors. Tuesday, July 10, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

21 CFR PART 11 Complete Manual for Compliance Success - Webinar GlobalCompliancePanel Overview: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. Tuesday, May 15, 2012  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized systems  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel ...criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old there are still many questions related to the scope  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more of the computer technologies.  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...ry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection- Webinar by GlobalCompliancePanel 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...

21 CFR Part 11 Auditing for Part 11 Compliance GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 18, 2010. Webinar will be presented by Jasmin NUHIC. 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...