25 JulThe Most Common Problems in FDA Software Validation & Verification – Webinar By GlobalCompliancePanel

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

In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S:

“The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11…The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections…”

The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures – and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a product or process step; and to match the V&V process to the product and risk.

Why you should attend:
Whether you’re planning to audit an internal IT system, anticipating an audit from a customer, preparing for the inevitable FDA inspection, or a vendor wishing to clearly demonstrate a software product is Part 11 compliant, this teleconference will give both old hands and new staff the practical information needed to understand the applicable regulations and solid methods to document compliance.
FDA inspectors are now being trained to evaluate software validation practices.
Increasing use of automated manufacturing and quality systems means increased exposure.
Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny.
A third of recent warning letters included citations with respect to improper or ineffective validation.
Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This presentation will review the validation planning process with particular emphasis on avoiding common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.
Areas Covered In the Seminar:
Outline of FDA regulations as applied to software.
Review of FDA software validation requirements.
Why validation makes good business sense.
Most Common Problems in FDA Software Validation & Verification.
Strategies on how to avoid the most common problems.
Advice on successful validation project staffing.
Who will benefit: The staff members who will benefit include:
System owners – responsible for keeping individual systems in validation
QA / QC managers, executives and personnel
Validation specialists
Software quality reviewers
Consultants
Price List:
Live : 5.00
Corporate live : 5.00
Recorded : 5.00

14 MayTurner Eye Institute Features the Only 400 Hz Excimer Laser in Northern California

Lining Eyes


Equipped with all the advantages of the proven Allegreto Wave ® technology, the Allegreto Wave ® Eye-Q is one step further towards optimum laser vision correction. Designed to work in perfect harmony with other diagnostic and surgical products from the WaveLight range, the Eye-Q provides both physician and patient with a higher level of safety and reliability.

Its state-of-the-art technology provides superior results with WaveLight’s Wavefront Optimized approach. Allegreto Wave ® lasers are the only systems to use Wavefront Optimized ablation profiles as part of their treatments. The use of Wavefront Optimized ablation prevents or reduces the induction of spherical aberrations. This results in a better night vision and less sensitivity to glare. The natural shape of the human cornea is aspheric. This means that all light rays meet in one sharp focus point. Therefore the Allegreto Wave laser systems perform an ablation with the objective of maintaining a natural postoperative corneal shape, thereby preserving the cornea’s asphercity. Every treatment is customized to the patient’s individual refraction and corneal curvature.

Featuring additional technological innovations, such as an enhanced pulse frequency of 400 Hz, a cross line projector and an eye-tracking system adjusted to the high speed of the laser beam, the Allegreto Wave ® Eye-Q offers the physician the opportunity of choosing the very best treatment for the patient available today.

The Allegreto Wave ® Eye-Q works with a pulse frequency of 400 Hz. This results in a correction time of only 2 seconds per diopter (considering a fully corrected optical zone of 6.5 mm). Thus, the average myopia correction takes about as little time as pouring a cup of coffee. The rapid repetition rate also results in expedited vision regeneration, more comfort for the patient and a minimization of influences from the external environment. Another advantage of both faster treatments and fewer post-treatment requirements is an optimized patient flow.

Speed is important for several reasons, but mainly because it increases outcome predictability and reduces the incidence of postoperative complications. Rapid treatment allows for the correction to take place while the eye is relatively dry, which can improve outcomes. It is also helpful with the treatment of patients who have higher prescriptions since their procedure is more time-intensive and this laser allows for a shorter, more comfortable experience.

The Allegreto Wave ® Eye-Q operates at the high speed of 400 pulses per second. Each ultra-thin laser pulse is used to sculpt the corneal surface with the utmost precision. In order to further enhance the safety and precision of the treatment, PerfectPulse Technology® uses advanced high-speed eye- tracking to follow the eye’s fastest movements and to ensure an accurate placement of each laser pulse on the cornea.

Finding the eye’s right treatment position and avoiding displacements caused by cyclotorsion is one of the most important factors in obtaining an excellent refractive outcome. The Allegreto Wave ® Eye-Q’s integrated cross line projector provides the surgeon an exact alignment of the eye’s position. The target diode generates a red light cross hair on the patient’s face, illustrating the correct position in coordination with the manual marks. With the Allegreto Wave ® Eye-Q you can also treat difficult cases or patients with a high cyclotorsion value up to 15% and still produce excellent results. This was demonstrated by the FDA clinical trials having a cornering predictability from ± 0.5 D.

Using a fine laser beam at such high speed, the Allegreto Wave ® Eye-Q relies on its 400 Hz synchronous, video-based, active eye-tracker to follow even the fastest eye movements with a response time of less than 6 ms. As a pupil-based system, it tracks pupils between 1.8 mm and 8 mm, and the automatic centering mode ensures perfectly centered ablations. The closed loop tracking mode reconfirms the eye’s location again before a pulse is placed on the cornea, to ensure that every pulse goes into the desired location. To monitor the patient’s eye, the active eye-tracker utilizes three infrared light sources. Being infrared, the illumination sources cannot cause thermal heating. The illumination sources are independent, meaning that the tracker will continue to work even if one of the pods is covered by the surgeon’s hand or a sterile drape, and the gooseneck shape of the illumination pods prevents backscattering of surgery.



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