'Warning letters' presentation slideshows

FDA Regulatory Requirements & The Food Safety Modernization Act

FDA Regulatory Requirements & The Food Safety Modernization Act. Presented by Anna Benevente , Senior Regulatory Specialist Registrar Corp October 2012. Seminar Overview. FDA: Background & Jurisdiction U.S. Agencies Regulating Food Products Key Food Regulations

2.24k views • 135 slides

Sandra Lee Esrael, Wisconsin Attorney San Francisco, California September 10-12, 2012

607 views • 55 slides

THE FDA TURNS A BLIND EYE CORPORATE & ACADEMIC MARKETERS SKEW SCIENCE / MEDICINE

A Multi-Headed Hydra Turned Medicine into Snake Oil Vera Sharav Alliance for Human Research Protection November 17, 2006 NARPA, Conference, Baltimore. THE FDA TURNS A BLIND EYE CORPORATE & ACADEMIC MARKETERS SKEW SCIENCE / MEDICINE DECEIVE DOCTORS RESULT: TAKING A MEDICINE

611 views • 54 slides

611 views • 49 slides

Texas Division

Texas Division. NTEPS Presentation September 24, 2009. Texas Division. Introduction To Federal Motor Carrier Safety Regulations . Why we do the things we do.

433 views • 28 slides

349 views • 25 slides

Direct-to-Consumer Advertising of Prescription Drugs: Current Issues

Direct-to-Consumer Advertising of Prescription Drugs: Current Issues. Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and Communications, FDA Marketing Pharmaceuticals in a Time of Change February 23, 2006. Talk Outline. Major influences in 2005 The year in DTC

450 views • 22 slides

Direct-to-Consumer Advertising of Prescription Drugs: Current Issues

Direct-to-Consumer Advertising of Prescription Drugs: Current Issues. Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and Communications, FDA Marketing Pharmaceuticals in a Time of Change February 23, 2006. Talk Outline. Major influences in 2005 The year in DTC

437 views • 22 slides

FDA Regulatory, Policy, and Enforcement Development Key Trends in 2015

FDA Regulatory, Policy, and Enforcement Development Key Trends in 2015. Debra S. Dunne, R.Ph., Esq. Partner | ddunne@shb.com Shook, Hardy & Bacon | 2001 Market Street, Suite 3000 | Philadelphia, PA 19103. Life Sciences Growth in 2015. Aging Population Chronic Diseases

179 views • 17 slides

CSA

CSA. Sergeant Steve L. Brown Office of Motor Carrier Compliance OMCC Director: Colonel David Dees. FMCSA v. OMCC. FMCSA is the federal agency responsible for development and enforcement of commercial motor vehicle rules.

358 views • 14 slides

FDA Enforcement Statistics Summary Fiscal Year 2012

156 views • 14 slides

LabCompliance Usersclub

LabCompliance Usersclub. Cost Effective Approach to Achieve FDA Compliance. Get instant access to over 500 documents Reference documents, Video clips, Presentations. LabCompliance Usersclub.

146 views • 10 slides

FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in Consent Decree

Understand current Food and Drug Administration (FDA) regulatory guidance as well as current regulatory trends with regards to consent decree.

316 views • 8 slides

FDA Enforcement Inspections

FDA Enforcement Inspections. FDA Inspections will use an underage person to monitor: 1) Mandatory ID under 27 all tobacco purchases. 2) Not selling to underage person (under 18). 3) Flavored and individual cigarettes not being sold. 4) No self-service displays. FDA Fine Schedule.

263 views • 7 slides

Investigating OOS Results

Description: This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

322 views • 7 slides

NORMAL DISTRIBUTION

NORMAL DISTRIBUTION

117 views • 5 slides

FDA Consultants

The FDA or Food and Drug Administration is the administrative authority liable for the monitoring and regulation of different types of cosmetics, foods, medical devices and pharmaceuticals. Established in 1927, it was originally formed from a reformation of the Bureau of Chemistry. With so many new drug warnings and recalls issued recently, the approval process of FDA has been in the news a lot.

207 views • 5 slides

FDA Computer System Validation Steps

The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.

514 views • 5 slides

How to tackle warning letters in Pharma Manufacturing?

Warning letters are issued by the FDA to people or associations for infringement of regulatory importance. https://qmssystems.com/

26 views • 2 slides

88 views • 1 slides