Pharmaceutical

Pharmaceutical
How Successfully Apply for a Breakthrough Therapy Designation
How Successfully Apply for a Breakthrough Therapy Designation

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the .....

$200.00
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?

Harvey Weinstein, Matt Lauer, Charlie Rose, Al Franken, Garrison Keillor, members of Congress, and v.....

$200.00
False Claims Act (or Whistleblower Act) and Hospital Fraud
False Claims Act (or Whistleblower Act) and Hospital Fraud

A whistleblower or qui tam action can provide financial rewards to individuals who provide informati.....

$200.00
Data Governance for Computer Systems Regulated by FDA
Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmace.....

$200.00
FDA Compliance and GAMP V Computer System Classification
FDA Compliance and GAMP V Computer System Classification

We will discuss the importance of classifying computer systems subject to FDA regulations in accorda.....

$200.00
Best Practices in Preparation for an FDA Computer System Validation Audit
Best Practices in Preparation for an FDA Computer System Validation Audit

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulate.....

$200.00
Best Practices for Investigating Deviations
Best Practices for Investigating Deviations

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigation.....

$200.00
Method Validation of HPLC/ UPLC Methods
Method Validation of HPLC/ UPLC Methods

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories th.....

$200.00
Acceptance Sampling for Variables: ANSI/ASQ Z1.9
Acceptance Sampling for Variables: ANSI/ASQ Z1.9

This webinar will show how to use ANSI/ASQ Z1.9 (formerly MIL-STD 414) to define sampling plans for .....

$200.00
Regulatory Affairs Project Management
Regulatory Affairs Project Management

This program will address approaches to regulatory affairs project management for clinical trial app.....

$200.00
Stability Studies and Estimating Shelf Life with Regression Models
Stability Studies and Estimating Shelf Life with Regression Models

Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of t.....

$200.00
Laboratory Investigation of Out-of-Specification (OOS) Results
Laboratory Investigation of Out-of-Specification (OOS) Results

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observa.....

$200.00
Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance
Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance

How can companies address the U.S. FDA’s tougher stance and product, process and QMS V&V. .....

$200.00
Validation of GC/ GC-MS methodologies
Validation of GC/ GC-MS methodologies

Instrumental gas chromatography, either as GC or GC-MS, are common techniques in laboratories that d.....

$200.00
Understanding Aseptic Technique and Cleanroom Behavior
Understanding Aseptic Technique and Cleanroom Behavior

Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination. .....

$200.00
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