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Regulatory Compliance training, Standards, Best Practices & News
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.
Featured Trainings
Compliance Trainings in Mar.
 
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
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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Corporate Governance
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FDA Compliance
Integrating QSIT into Quality Plans
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Food Safety Compliance
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Green Compliance
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Compliance Standards
Graphical symbols for diagrams - Part 10: Fluid power converters
Price: $80
Powered industrial trucks -- Safety signs and hazard pictorials -- General principles
Price: $129
Manually portable agricultural and forestry machines and powered lawn and garden equipment - Design principles for single-panel product safety labels
Price: $65
Fluid power systems and components - Graphic symbols and circuit diagrams - Part 1: Graphic symbols for conventional use and data-processing applications
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