Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
: Norma Skolnik
Recorded Webinar

This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Adverse.....

$200.00
How Successfully Apply for a Breakthrough Therapy Designation
How Successfully Apply for a Breakthrough Therapy Designation
: Carolyn Troiano
Recorded Webinar

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the developme.....

$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?
: Susan Strauss
Recorded Webinar

Harvey Weinstein, Matt Lauer, Charlie Rose, Al Franken, Garrison Keillor, members of Congress, and various State lawmakers have been accused of sexual harassment and/or sexual assault. But there is a difference between pulling one’s pants down in front of a female colleague at work and touching a woman on her buttocks during a photo op—isn’t there? What is that difference? Are both examples considered sexua.....

$200.00
False Claims Act (or Whistleblower Act) and Hospital Fraud
False Claims Act (or Whistleblower Act) and Hospital Fraud
: Shauna Itri
Recorded Webinar

A whistleblower or qui tam action can provide financial rewards to individuals who provide information that a company, hospital or individual has defrauded the government. The primary statutes under which this relief may be sought are the federal and state False Claims Acts (“FCAs”). State and federal governments pay hundreds of billions of dollars each year for pharmaceutical drugs, medical devices, hospit.....

$200.00
Data Governance for Computer Systems Regulated by FDA
Data Governance for Computer Systems Regulated by FDA
: Carolyn Troiano
Recorded Webinar

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st.....

$200.00
FDA Compliance and GAMP V Computer System Classification
FDA Compliance and GAMP V Computer System Classification
: Carolyn Troiano
Recorded Webinar

We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP V. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that you do not go beyond what is required for a specific classification of the system so as to be cost-effective......

$200.00
Best Practices in Preparation for an FDA Computer System Validation Audit
Best Practices in Preparation for an FDA Computer System Validation Audit
: Carolyn Troiano
Recorded Webinar

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more .....

$200.00
Best Practices for Investigating Deviations
Best Practices for Investigating Deviations
: Danielle Delucy
Recorded Webinar

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum.....

$200.00
Method Validation of HPLC/ UPLC Methods
Method Validation of HPLC/ UPLC Methods
: John C Fetzer
Recorded Webinar

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis is widely used to determine purity, the impu.....

$200.00
Acceptance Sampling for Variables: ANSI/ASQ Z1.9
Acceptance Sampling for Variables: ANSI/ASQ Z1.9
: William Levinson
Recorded Webinar

This webinar will show how to use ANSI/ASQ Z1.9 (formerly MIL-STD 414) to define sampling plans for products with continuous-scale (variables) data, and use the accompanying switching rules to move between normal, reduced, and tightened inspection as required by the publication.ANSI/ASQ Z1.9 (formerly MIL-STD 414) is a widely accepted standard for sampling by variables (continuous scale measurements). The s.....

$200.00
Regulatory Affairs Project Management
Regulatory Affairs Project Management
: Peggy J Berry
Recorded Webinar

This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.Learning ObjectivesSetting tasks focused on projec.....

$200.00
Stability Studies and Estimating Shelf Life with Regression Models
Stability Studies and Estimating Shelf Life with Regression Models
: Steven Wachs
Recorded Webinar

Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the method(s) chosen often depend on the testing time available.This webinar discusses the steps to set-up a stability study and analyzes the results to .....

$200.00
Laboratory Investigation of Out-of-Specification (OOS) Results
Laboratory Investigation of Out-of-Specification (OOS) Results
: John G Lanese
Recorded Webinar

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that ar.....

$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
: John E Lincoln
Recorded Webinar

How can companies address the U.S. FDA’s tougher stance and product, process and QMS V&V? One major failing is the lack of sufficient or targeted risk-based V&V Master Planning. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems/documents? How should each individual V&V plan be structured? Clarification of validation terms. Device, product, proce.....

$200.00
Validation of GC/ GC-MS methodologies
Validation of GC/ GC-MS methodologies
: John C Fetzer
Recorded Webinar

Instrumental gas chromatography, either as GC or GC-MS, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental gas chromatography is an analysis is widely used to determine purity, the impurities,.....

$200.00
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