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May
23

FDA Warning Letter - Consent Decree Software Validation - Webinar By ComplianceOnline

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

This FDA warning letter Webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.

Areas Covered in the seminar:

Organizer: 
ComplianceOnline
More information about FDA Warning Letter - Consent Decree Software Validation - Webinar By ComplianceOnline »
May
23

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel

Webinar |Online Training, Wilmington, United States
May 23, 2012 | 0 people are attending

Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. 

Organizer: 
GlobalCompliancePanel
More information about DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel »
May
24

Configuration Management and Change Control for Networks and Computer Systems

Webinar |Online, Online, United States
May 24, 2012 | 1 people are attending

This seminar will discuss how to control changes of hardware, firmware, software and documentation of computer systems and netorks

Why to attend:
   

Organizer: 
Labcompliance
More information about Configuration Management and Change Control for Networks and Computer Systems »
May
24

Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel

Webinar |Online Training, Wilmington, United States
May 24, 2012 | 0 people are attending

Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. 

Organizer: 
GlobalCompliancePanel
More information about Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel »
May
24

The A to Z’s of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems

Conference |Renaissance Newark Airport Hotel 1000 Spring Street, Elizabeth, New Jersey, United States
May 24, 2012 - May 25, 2012 | 0 people are attending

Course Description :

Organizer: 
ComplianceOnline
More information about The A to Z’s of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems »
May
29

Early Stage Clinical Development

Conference |Revere Hotel Boston, Boston, United States
May 29, 2012 - May 31, 2012 | 0 people are attending

How innovative approaches to early stage clinical trial design can guarantee you late stage success

Now is the time for you to increase the efficiency of your early stage clinical development program. With rising R&D costs & decreasing approval rates, optimizing your approach to early stage clinical development has never been more important. Do you have a plan in place?  

Organizer: 
Hanson Wade
More information about Early Stage Clinical Development »
May
30

Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars

Webinar |OnlineEvent, CA, United States
May 30, 2012 | 0 people are attending

This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.

Description: 

Why Should You Attend:

Organizer: 
ComplianceOnline
More information about Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars »
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
7

Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment

Conference |Hyatt Regency Columbus 350 North High Street, Columbus, Ohio, United States
June 7, 2012 - June 8, 2012 | 0 people are attending

Course Description:

Organizer: 
ComplianceOnline
More information about Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment »
Jun
12

FDA Warning Letter Closeout Program - Webinar By ComplianceOnline

Webinar |Online Event, Palo Alto, CA, United States
June 12, 2012 | 0 people are attending

This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.

Why Should You Attend:
FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. Part of the "new FDA" is the increased issuance of warning letters and the creation of a warning letter "closeout", which regulated firms can use to your advantage.

Organizer: 
ComplianceOnline
More information about FDA Warning Letter Closeout Program - Webinar By ComplianceOnline »
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