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Jun
7

Designing effective and efficient Extractables/leachables studies - Webinar By ComplianceOnline

Webinar |Online Event, Palo Alto, CA, USA
June 7, 2012 | 0 people are attending

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

Why Should You Attend:

Organizer: 
ComplianceOnline
More information about Designing effective and efficient Extractables/leachables studies - Webinar By ComplianceOnline »
Jun
7

CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

Webinar |Online Event, Palo Alto,CA, USA
June 7, 2012 | 0 people are attending

This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.

Attend this webinar to understand the differences and the proper methods to meet the guidelines. It is important to understand that measuring quality is essential to assessing quality. The measurement of processes and the outcomes is the only way to truly assess quality.

Areas Covered in the Seminar:

Organizer: 
ComplianceOnline
More information about CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment »
Jun
27

Trial Master File for Research Sites: Can You Pass FDA Inspection?

Webinar |Online Event, Palo Alto, CA, USA
June 27, 2012 | 0 people are attending

This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.

Why Should You Attend: Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.

Organizer: 
ComplianceOnline
More information about Trial Master File for Research Sites: Can You Pass FDA Inspection? »
Jun
29

EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Webinar |Online Event, Palo Alto, CA, USA
June 29, 2012 | 0 people are attending

Why Should You Attend:

This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.

Key Topics to be Discussed:

Organizer: 
ComplianceOnline
More information about EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs »
Jun
29

Eliminate the Confusion - New 2012 Requirements for Clinical Laboratories to Meet GCP

Webinar |Online Event, Palo Alto, USA
June 29, 2012 | 0 people are attending

This webinar on Good Clinical Practices will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.

Organizer: 
ComplianceOnline
More information about Eliminate the Confusion - New 2012 Requirements for Clinical Laboratories to Meet GCP »
Jul
25

Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry

Webinar |Online Event, Palo Alto, USA
July 25, 2012 | 0 people are attending

This 3-hr Latin America Regulatory compliance requirements training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

Why Should You Attend:

Organizer: 
ComplianceOnline
More information about Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry »

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