fda News

At a German cheese producer, glass-free pH sensors from METTLER TOLEDO are being successfully used to control cultivation of starter culture in fermentation reactors. The sensor fully meets strict process safety requirements.

This summit (part of CHI's Third Annual Immunogenicity Summit) is scheduled for November 17-18, 2011 at the DoubleTree Hotel in Bethesda, MD.

This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations,

"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.

This summit (part of CHI's Third Annual Immunogenicity Summit) is scheduled for November 16-17, 2011 at the DoubleTree Hotel in Bethesda, MD.

Domain Surgical, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its FMwand(TM) Ferromagnetic Surgical System for soft tissue cutting and coagulation.

This Food Safety Modernization Act training will provide an introduction to and summarize the key provisions of FSMA. The implementation schedule and potential expectations for food manufacturers and processors will also be outlined.

At CHI's Companion Diagnostics as an Integral Part of Personalized Medicine conference on Aug. 24-25 in D.C., national and global experts Stafford O'Kelly of Abbott Molecular and Richard Ding of bioMerieux, host keynote session.

"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.

Who will benefit: Quality Control Laboratory Manager Warehousing Purchasing Managers Procurement Managers Laboratory Analyst Cost Accounting

ReBuilder Builder Medical Technologies, Inc. announced today that it has entered negotiations to acquire its manufacturing affiliate Medical Rebuilder, Inc. Negotiation should be completed soon with an August 1, 2011 closing date.

ReBuilder Has Contracted With A National Billing Company Experienced In Medicare Billing Procedures Which Lends A Degree Of Enhanced Professionalism And Capability In The Marketplace.

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback.

New Pharmaceuticals market report from Datamonitor: "R&D Trends: Systemic Lupus Erythematosus - Benlysta's FDA approval provides hope for disease treatment, future trial design, and other pipeline candidates"

An examination of publicly available FDA data by Emergo Group on 510(k) clearances over the last five years indicates that 80% of devices receive clearance within six months.

On Tuesday, the Food and Drug Administration [FDA] will announce what the new enhanced warnings on cigarette packs will look like. A very recent comprehensive report provides the best available information for the media and others.

MedTech announced support for Competitiveness Agenda released by AdvaMed on June 6, 2011; MedTech's 2011 Annual Conference, Sept. 13 in Rochester, NY, will address the subjects of collaboration and competitiveness.

The seminar will train companies in FDA regulated industries on proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

The seminar will serve regulatory and quality professionals in Medical Device companies by helping them create effective Risk Management and Quality Management Systems.

This 21 CFR Part 11 webinar/training will discuss on the technical details required by technical personnel to understand, communicate and implement part 11 compliance in to computer systems regulated by FDA.

The FDA has ramped up surveillance and we have seen an increase in the number of warning letters issued to manufacturers.

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

Fuerst Ittleman, a Miami, Florida FDA Law firm, launched a website

Linium's SAM expert Chris Borkert explores the world of software development regulations for the FDA in his recent article Life Sciences and Software Compliance - More Software Regulations for Software in Medical Devices in ITAK Magazine.

This conference will take place on Aug. 16-17, 2011, Cambridge, MA. Experts from vaccine manufacturers, suppliers, quality control, and platform development gather to learn new technologies & advance the field of vaccine & therapeutic manufacturing.

This webinar will clearly explain the regulatory requirements (FDA, USP, ICH, EMA) for Validation of Analytical Methods and Procedures and present practical approaches for implementation.

Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan.

inLife, LLC, global distributors of the electronic cigarette (e-cig) and one of the founding companies in this new industry, applauds the FDA in now regulating the electronic cigarette as a tobacco product.

There is an immense amount of excitement and hope brewing among the SLE population with the recent FDA approval of the lupus treatment, Benlysta® (belimumab). However, it isn't for everyone battling with Lupus.

The Revo MRI™ SureScan® pacing system, the first and only pacemaker in the U.S. specifically designed for use in a MRI environment, was approved by the U.S. Food and Drug Administration (FDA) On February 8, 2011.

The South Florida Cancer Association announced today a partnership agreement with the U.S. Food and Drug Administration involving the Office of Women’s Health Take Time to Care (TTTC) outreach initiative.

This Deviation, Investigation and CAPA training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries

It will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.

This training on FTC’s New Substantiation Standards will provide an comprehensive understanding of the new standards, when they will apply and how you can satisfy them.

This webinar on Retirement of Computer Systems will give a good understanding of FDA and equivalent international requirements and will provide recommendations and tools for effective implementation.

This webinar will cover the basics on how to maintain a good Design History File that will help a manufacturer during a regulatory compliance audit

This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.

Though it can cost hundreds of thousands of dollars to respond to a single Form FDA 483, many pharma manufacturers aren’t taking some of the basic steps needed to avoid being cited, according to new research published by FDAzilla.

This May, Joao Pedras-Vasconcelos, Visiting Associate, Therapeutic Proteins CBER from FDA will meet with European industry experts at Pharma IQ's to discuss FDA directives on Immunogenicity introduced in 2008.

Registration is open for ULTRAPURE WATER Pharma, planned for April 12-13 in Philadelphia. The meeting will focus on key topics related to pharmaceutical water treatment. More details are available at www.ultrapurewater.com.

Today marks a major advance in the fight against skin cancer, as the U.S. Food and Drug Administration (FDA) approved a new immune-based therapy for the treatment of melanoma, the leading cause of death from skin cancer.

Agenda released for first-ever West Coast conference

To Share Lead with sanofi-aventis’s Kevin Malobisky

The report provides a comprehensive insight into the biosimilar market. It offers geography-wise as well as category-wise market forecasts for biosimilars and provides the drivers and restraints affecting the biosimilars market.

Registration is now underway for ULTRAPURE WATER Pharma/Emerging Technologies. The April 12-13 conference will focus on pharmaceutical water issues and new technologies relevant to water treatment. To register visit www.ultrapurewater.com

This training will help you understand FDA expectations for reduced testing of Pharmaceutical & Medical Device components and will develop your confidence in maintaining control of supplier quality.

This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance.

This Disinfection and Cleanroom Cleaning training will teach you how to choose the best disinfectants, know the different performance parameters of disinfectants, methods to qualify disinfectants, writing and executing cleaning procedures.

Manufacturer's line of products to treat snoring and sleep apnea cleared with assistance from Emergo Group.