Delaware Medical News (United States)

ILC Dover annouced today that the National Institute for Occupational Safety and Health has approved its Sentinel XT as a Loose Fitting PAPR.

FyMed, Inc., a biopharmaceutical company today announced strategic and operational expansion plans following the successful completion of major preclinical drug studies utilizing proprietary companion diagnostics and prognostic technologies.

DHA’s mobile medical unit traveled to Rehoboth Beach in June to provide spay/neuter surgery and vaccinations for over 60 cats at no cost thanks to funds raised by their annual Walk for the Animals at the Beach.

Medicalbillersandcoders.com have announced the availability of the medical transcriptionist who service hospitals, clinics and physician offices across the US.

All While Helping More than 65,000 New Customers Save OVER $1,000,000 in Just 16 weeks.

Imagine if you could GIVE something away for FREE, and every time it was used, you got paid… Sounds good, doesn't it?

Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s

While many health providers recommend to those with food allergies and intolerances to avoid the foods they are sensitive to, new evidence hows how to reverse food allergies using inexpensive and natural methods.

Medisweans is a subsidiary of Sweans technologies based in US, announces its latest measures on the wake to fasten the payment processing. In order to help its clients get paid faster, the company has enhanced its existing web based software.

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions

In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates.

If you handle any electronic patient information, don’t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation.

In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other,

This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process.

The principal objective in a new drug development program is to assess the benefit / risk ratio.

This webinar will provide an overview of process validation for devices and pharmaceuticals.

Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing.

This webinar will address these complexities and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements.

CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM.

The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.

Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.

This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints.

This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical

This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure.

This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation.

His webinar will provide valuable assistance and guidance to device companies in involved in labeling changes.

This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.

This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers.

Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue.

Data Security Analysis for Healthcare Providers: The "meaningful use" rules relating to the adoption of Electronic Medical Records require regular assessment of data security risks. HIPAA re-contains similar requirements.

The Cloud Computing / Software as a Service (SaaS) Webinar will present the best practices for the validation of a SaaS Customer Relationship Management (CRM) Solution.

This course provides the attendees with the tools needed to understand and implement acceptance sampling.

This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.

As anyone that has been involved in a traditional paper-based validation project can attest to the ability to manage the validation deliverables, timelines, resources, tasks and the compliance of the project can be difficult

The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572.

InfoQuest Systems Inc. has received the federal government’s “meaningful use” stamp of approval by earning Complete Ambulatory EHR certification.

This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables.

This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies.

FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.

The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested.

ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards.

Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating,

This webinar will discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System.

This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data.

As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs.

Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology