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Cervical orthosis Ethafoam is an advanced collar with scientific design which ensures complete immobilization on one hand and perfect comfort on the other. It is called as a gold standard in cervical immobilization. Ultimate comfort. Perfect immobilization. Anatomically moulded. Minimal contact surface. Hypoallergenic. Cervical Orthosis (Philadelphia) Ethafoam Features Pre-formed chin Provides rest to the chin, ensures comfort, improves immobilization. Anatomical and balloon design Offers perfect immobilization, minimal contact of the neck, allows use in burn or trauma patients. Hypoallergenic materials Ensures no rash or allergy even on prolonged use, compatible to geriatrics, better patient compliance . Tracheotomy opening Compatible to use of endotracheal tube, improves air ventilation, improves patient comfort and compliance. Two piece design Easy application, firm occipital support, option for varying rigidity. Ethafoam Light weight, better patient compliance, non absorbent ensures easy cleaning and maintenance.

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Tynor Cervical Orthosis Plastazote Cervical orthosis plastazote is an advanced collar with scientific design which ensures complete immobilization on one hand and perfect comfort on the other, It is called as a gold standard in cervical immobilization. Ultimate comfort. Perfect immobilisation. Anatomically moulded. Minimal contact surface. Hypoallergenic. Tynor Cervical Orthosis (Philadlphia) Plastazote Features Pre-formed chin Provides rest to the chin, ensures comfort, improves immobilization. Anatomical and balloon design Offers perfect immobilization, minimal contact of the neck, allows use in burn or trauma patients. Plastazote Light weight, better patient compliance. Non absorbent ensures easy cleaning and maintenance Hypoallergenic, Ensures no rash or allergy even to old age patients Eco friendly manufacturing process Better patient compliance Tracheotomy opening Compatible to use of endo tracheal tube, improves air ventilation. Improves patient comfort and compliance. Two piece design Easy application, firm occipital support, option for varying rigidity. Better immobilization Tynor Cervical Orthosis (Philadlphia) Plastazote Measurements Measure distance between edge of sternum and lower jaw with neck in extension position.

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

The alerts moderately increased adherence to the guidelines, as compared with a control group of practices that did not have access to the alerts but could make use of embedded asthma tools if they proactively entered and searched the electronic record.