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Regulatory Compliance training, Standards, Best Practices & News |
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| Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands. |
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Quality by Design - Integrating your product and process development into your submission with QbD
Instructor : Peter Calcott
Live Tuesday, February 9, 2010 | 10:00 AM PST | 01:00 PM EST
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Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>
Instructor : Scott Sutton
Live Tuesday, February 9, 2010 | 10:00 AM PST | 01:00 PM EST
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Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection
Instructor : Jeff Kasoff
Live Tuesday, February 9, 2010 | 10:00 AM PST | 01:00 PM EST
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International Financial Reporting Standards (IFRS): First time adoption
Instructor : Mike Morley
Live Tuesday, February 9, 2010 | 10:00 AM PST | 01:00 PM EST
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FDA Warning Letter Closeout Program
Instructor : Alfonso Fuller
Live Wednesday, February 10, 2010 | 10:00 AM PST | 01:00 PM EST
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Governance, Risk & Compliance: Developing a holistic approach to governance
Instructor : James Bone
Live Wednesday, February 10, 2010 | 10:00 AM PST | 01:00 PM EST
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Advanced Process Auditing Techniques for Medical Device/Pharma Quality Systems
Instructor : Angelo Scangas
Live Wednesday, February 10, 2010 | 09:00 AM PST | 12:00 PM EST
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Selection and Use of (Certified) Reference Material- Strategies for FDA Compliance and Tools for Implementation
Instructor : Dr. Ludwig Huber
Live Tuesday, March 2, 2010 | 10:00 AM PST | 01:00 PM EST
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Effective Process Audit Discussion - A practical approch
Instructor : Diane Bove
Live Tuesday, March 2, 2010 | 10:00 AM PST | 01:00 PM EST
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Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation
Instructor : Barry Craig
Live Wednesday, March 3, 2010 | 10:00 AM PST | 01:00 PM EST
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EU's MDD Mod 5 Changes due March 2010 - Impact on CE-mark Compliance
Instructor : John E Lincoln
Live Wednesday, March 3, 2010 | 10:00 AM PST | 01:00 PM EST
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The Role of Investigative Toxicology and Safety Biomarkers in Drug Safety Evaluations
Instructor : Paula J Lapinskas
Live Thursday, March 4, 2010 | 10:00 AM PST | 01:00 PM EST
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Food cGMP's 101: Understanding cGMP’s in relation to your Quality System to assure FDA compliance and high quality products
Instructor : Phil Guarino
Live Thursday, March 4, 2010 | 10:00 AM PST | 01:00 PM EST
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Electronic Data Capture (EDC) and Electronic Health Record (EHR) in Clinical Trials: Collecting and Leveraging Data to Optimize Clinical Trials
Instructor : Ingrid Koster
Live Tuesday, March 9, 2010 | 10:00 AM PST | 01:00 PM EST
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Article of this Week |
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Nonclinical Safety Evaluations in Drug Development
This review is designed to provide a basic overview of the first webinar topic“Nonclinical Drug Safety Evaluations in Drug Development” which will be discussed in detail in the webinar. This overview will outline key aspects of the overall drug development process with focus on the role of nonclinical safety evaluations at each stage of the development; provide definitions of key terminology used in nonclinical toxicology and where appropriate, literature references to provide webinar attendees more detail on key topic areas. In the webinar, an overview of the state-of-the-art non-clinical approaches and the data sets necessary to make key decisions to progress a compound forward in drug development will be reviewed. Three key decision points are addressed: Drug discovery (focus on lead optimization), nonclinical (or preclinical) safety evaluations prior to first-in-human studies and clinical development and nonclinical studies required for marketing decisions. The webinar discussions will focus primarily on small-molecule drugs (i.e. drugs with a molecular mass (MM) < 1,000). This webinar is the first in a 3 part series on nonclinical safety from ComplianceOnline. In a webinar titled “Practical Applications of the ICH, OECD and other relevant regulatory guidance's in Drug Development” the ICH and other key regulatory guidance's that pertain to nonclinical drug development will be reviewed and discussed in details. In the third webinar, titled “The Role of Investigative Toxicology and Safety Biomarkers in Drug Safety Evaluations”, the application of innovative toxicology approaches that are being used to minimize the rate of attrition, facilitate earlier data-driven decisions and deliver safer leads into development or position the finding(s) as they relate to Human will be discussed. This review and the first webinar will focus mainly on the standard “best practices” in nonclinical evaluations for each stage of drug development. |
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