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Jun
5

ICH Q10; moving from GMPs to a Pharmaceutical Quality System - Webinar By ComplianceOnline

Webinar |Online Event, Palo Alto, United States
June 5, 2012 | 0 people are attending

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.

Why should you Attend:

Organizer: 
ComplianceOnline
More information about ICH Q10; moving from GMPs to a Pharmaceutical Quality System - Webinar By ComplianceOnline »
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 »
Aug
23

Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees

Webinar |Online Event, Palo Alto, United States
August 23, 2012 | 0 people are attending

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable.

Why Should You Attend:

Organizer: 
ComplianceOnline
More information about Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees »
Sep
18

Risk Assessment-Compliance Using Easy To Fill Out Documentation

Webinar |Online Event, Palo Alto, United States
September 18, 2012 | 0 people are attending

Learn how to perform risk assessment as part of the risk-based approach to computer system validation.

Why Should You Attend:

Organizer: 
ComplianceOnline
More information about Risk Assessment-Compliance Using Easy To Fill Out Documentation »
Mar
8

Managing Immunogenicity Risk in Biopharmaceuticals - Webinar By ComplianceOnline

Webinar |Online Event, Palo Alto, United States
March 8, 2013 | 0 people are attending

Why Should You Attend:

This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of biopharmaceuticals. The next section describes how to differentiate the risk associated with internal attributes of the drug from the risk derived from external factors. That guideline in conjunction with the latest industry recommendations and regulatory guidelines provides a logical approach to the risk strategy.

Organizer: 
ComplianceOnline
More information about Managing Immunogenicity Risk in Biopharmaceuticals - Webinar By ComplianceOnline »

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