Events
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The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Learn more: www.practicepaysolutions.com/mastery Join us for a free series of one-hour webinars with the a team of industry experts! We're presenting the less-covered, critical issues for small business owners, so you can reduce the time you spend on set-up and administration-- and focus on what really matters. Can't attend live? We'll send you the call recordings so you can access valuable information and share the event with your community! April 2nd: The Joy of Productivity with George Kao April 16th: How to Create Profitable Referral Partnerships with Robert Notter April 24th: Say Bye-Bye to Your Boring Bio with Nancy Juetten May 15th: From Contacts to Contracts with Caterina Rando May 22nd: Red Fire Profitability with Liz Goodgold June 5th: Developing Contracts & Service Agreements with Tasha Cooper Coleman June 19th: Outsourcing Secrets with Travis Greenlee July 10th: Your Money Relationship = Your Business Success with Helen Kim July 24th: How to Play a Bigger Marketing Game with Fabienne Fredrickson Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children, or want to work with children, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit. Start: 07/17/2012 7:10 am
Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device, a less complex CE Marking Technical File may be required. In the case of Class IIa, IIb and Class III devices, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier). Once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. Whereas the expression "Technical File" is usually associated with Class I, IIa and IIb, and "Design Dossier" for class III products., the files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which have already been subject to an ISO/MDD type Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower-level documents. A brief summary of manufacturing processes (flow chart including inspection and preventive monitoring steps) and validation of sterilization processes should be included in the design dossier. Be prepared to review all elements that comprise these documents and address recommended best practices. Areas covered in the session: Who will benefit: This webinar will provide valuable assistance and guidance to medical device companies responsible for constructing and managing their Technical Files and Design Dossiers. Employees who will benefit include: Start: 07/17/2012 7:10 am
Overview: This webinar will start by covering ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques. The information obtained from these specialized studies is critical in developing optimized lyophilization cycles and formulations without having to use a "trial and error" approached, which is still commonly used by many companies who don’t understand the science behind freeze-drying. Next, webinar will focus on using what was learned above to develop an optimized, cGMP compliant formulation that is specifically designed for lyophilization. In depth discussions will be included on a pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents. Additionally, time will be dedicated to tying everything learned from the pre-formulation studies into designing an optimal formulation tailored specifically for our molecule of interest. Finally, the webinar will conclude with a discussion on the specialized aspects of designing a formulation for large, biomolecule formulations, and the analytical techniques used drive this process. Why you should attend: Companies developing new formulations and lyophilization cycles must be able to explain, scientifically, why they have chosen each excipient they have added to a formulation, why they are using as much as they have added, what are the critical temperatures of the products (glass transition temperature, Tg’ or eutectic melting temperature, Te), etc. Companies that cannot produce this type of information run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin. The topics described in this session will cover all of the aspects of understanding the justification for freeze-drying, the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used to develop a stable, optimized, cGMP compliant product. At the end of the session, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them. By understanding and applying these principles, companies have a much greater chance of getting products approved by the Regulatory agencies than those companies that employ the "trial and error" approach to formulation and lyophilization cycle design. Areas Covered in the Session: Who Will Benefit: This webinar will provide valuable assistance to those companies involved developing formulations and lyophilization cycles, or in lyophilization product manufacturing. Those who would benefit from this webinar include: Start: 07/17/2012 10:00 am
End: 07/17/2012 11:00 am
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development. Why Should You Attend: Auditing is essential to ensuring quality assurance of drug development. Each audit has a degree of complexity which needs effective project management. With ever increasing pressures to complete the audit promptly and to the appropriate quality standard, the effective use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of efficient auditing. This presentation will provide you with an excellent understanding of project management skills, to apply to auditing in all GXP areas. You will be provided with an integrated project tool kit which can easily be used with your existing or future project management tools used for auditing. This tool kit has been used to significantly improve the successful completion of auditing on time to the right quality standard in many pharmaceutical organisations. The presentation will show you how to use these project management skills to gain the most benefit from them in your auditing activities. Areas Covered in the Seminar: - What is a Project Management framework for auditing? Start: 07/17/2012 10:00 am
End: 07/17/2012 11:30 am
This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach). This webinar describes exactly what is required to be 21 CFR Part 11 compliant. It takes the concepts of Part 11 and expands them into specific things to do in all three primary areas: SOPs, product features, and validation. All required IT SOPs are described. Product features based on the current industry standards are explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood. This is the first webinar in a series and it takes the mystery out of what is needed for 21 CFR Part 11 compliance. It will help you to eliminate 483s and Warning Letters. Areas Covered in the Seminar:
Start: 07/17/2012 2:00 pm
During this one-hour webinar we will discuss human neuropsychological development in infants, the many interacting factors, and how emotions shape the way the cortical systems exert control over limbic areas. Full Description: Course Includes: What You Will Learn: Your Presenter: Disclaimer: Technical requirements: Who Should Attend: | ||
