Join Diana Larsen for a lively talk about ways to launch projects and teams on the
trajectory to high performance, hyper-productivity, and successful, high value
delivery.
Diana will tell stories of real-world project starts and show how you can
create a "booster rocket" to help your team gain early momentum and accelerate into...
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Join Diana Larsen for a lively talk about ways to launch projects and teams on the trajectory to high performance, hyper-productivity, and successful, high value delivery. Diana will tell stories of real-world project starts and show how you can create a "booster rocket" to help your team gain early momentum and accelerate into action. Launching Projects and Teams for High Performance and Hyper-Productivity Speaker:Diana Larsen Attendance is Free Event organizer: Trifork A/S More Information about the GeekNight: Launching Projects and Teams for High Performance and Hyper-Productivity at http://itevent. net/geeknight-launchingprojects-and-teams-for-high-performance-and-hyper-productivity Trifork A / S develops, sells and delivers IT solutions for the financial and public sector in Denmark. In our academy we organize software development conferences, courses and organizes technological networks, nationally and internationally. Trifork A / S has 130 employees in offices in Aarhus, Cop
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From Tim Linen
This Conference helps to understand how to create a value for your organization by
systematically recording assets, processes, connectivity, people, timing &
motivation through a simple framework (Zachman Framework).
It will reduce decision
risk & technology cost.
As you know, Zachman Framework is world s most proven model for...
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This Conference helps to understand how to create a value for your organization by systematically recording assets, processes, connectivity, people, timing & motivation through a simple framework (Zachman Framework). It will reduce decision risk & technology cost. As you know, Zachman Framework is world s most proven model for aligning IT Investments & Business Goals. It has been applied for managing change & complexity in several Global 2000 organizations. What you will learn: 1. Understand the multi-dimensional view of business-technology alignment. 2. A sense of urgency for aggressively pursuing Enterprise Architecture. 3. A definition (description) of Enterprise Architecture. Learn how to clearly view an enterprise from multiple dimensions in order to cut through complexity and see the Big Picture. 4. A "language" (i. e. , a Framework) for improving enterprise communications about architecture issues. 5. An understanding of basic Enterprise physics. 6. An understand
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From Tim Linen
Compliance with compendial standards for residual solvents is required for all drug
products provided in the United States, and similar requirements exist in all the
major markets of the world.
Since every product is unique, and since the
requirements refer to over 50 different solvents, achieving compliance can be very
challenging....
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Compliance with compendial standards for residual solvents is required for all drug products provided in the United States, and similar requirements exist in all the major markets of the world. Since every product is unique, and since the requirements refer to over 50 different solvents, achieving compliance can be very challenging. Many, many firms have received incomplete or warning letters from the FDA as a result of failure to adequately address the reporting of residual solvents. This course is designed to provide participants with practical strategies for complying with regulatory requirements for residual solvents while minimizing resource requirements. The course will address FDA expectations, understanding the potential sources of residual solvents in drug products, appropriate analytical methodology and strategies for characterizing solvents in components and in drug product. The course will address reporting levels of residual solvents, and conclude with an opportunity
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From Tim Linen
Why Should You Attend:
Effective implementation of the international management systems can bring great
rewards in identifying inefficiencies in your day-to-day operations.
And this
directly translates to cost savings.
Are you getting the value added to each registration auditor visit or is it the
same review of documents and...
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Why Should You Attend: Effective implementation of the international management systems can bring great rewards in identifying inefficiencies in your day-to-day operations. And this directly translates to cost savings. Are you getting the value added to each registration auditor visit or is it the same review of documents and auditors hiding in conference rooms? Many organizations are not taking full advantage of these international management systems, mainly financial opportunities. This webinar is a way to discuss implementation problems, registration problems, interpretation of the standards, selling management on a management system, all with the anonymity of a web cast. Use this webinar as a forum to hear what others are thinking and share in the give and take of what works and what doesnt work for you. Attendance cost: 349$ Event organizer: ComplianceOnline Get more information and register for the Understanding the ISO 9001, 14001 and OHSAS 18001 Process at http://itevent.
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From Tim Linen
Government efforts to enforce immigration laws have increased over the last five or
six years.
More and more companies are facing penalties for immigration violations.
The Obama Administration has made it clear that the burden of enforcement will fall
squarely upon employers.
The current administration disdains the use of raids and...
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Government efforts to enforce immigration laws have increased over the last five or six years. More and more companies are facing penalties for immigration violations. The Obama Administration has made it clear that the burden of enforcement will fall squarely upon employers. The current administration disdains the use of raids and public seizure of persons or assets and instead focuses upon audits of employer I-9 forms, imposition of severe civil penalties, and the attendant publicity. The recent settlement by Abercrombie and Fitch of an I-9 sanctions case for over $1 million demonstrates that it is dangerous for employers to rely upon software for proper I-9 compliance. Today, in order to avoid huge fines and possible criminal liability, employers need to be much more vigilant and diligent. Attend this webinar to stay informed about current enforcement trends and tactics. Learn what industries are being targeted for enforcement and why. You will also understand what the gover
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From Tim Linen
Qualification and calibration of analytical instruments is a key component of CGMPs
in each of the major regions.
Calibration failures for dissolution instruments have
plagued the industry for many years.
This is not unexpected, since the dissolution test is more challenging than many
other analytical tests, since it involves...
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Qualification and calibration of analytical instruments is a key component of CGMPs in each of the major regions. Calibration failures for dissolution instruments have plagued the industry for many years. This is not unexpected, since the dissolution test is more challenging than many other analytical tests, since it involves chemical and physical factors that are changing in a very rapid timeframe. In the last several years there has been a lot of change related to qualification of dissolution instruments. Compendial chapters on dissolution have been harmonized globally, USP introduced a new format for acceptance criteria for the Performance Verification Test, added a Toolkit to aid executing the PVT, and FDA (and others) have indicated that Enhanced Mechanical Calibration (without the use of calibrator tablets) can be an acceptable approach for qualification of these devices. This course is designed to provide participants with an understanding of the requirements for dissolutio
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From Tim Linen
Analytical methods play a key role in assuring that drug substances and drug
products conform to their specifications.
Demonstrating that these methods
consistently perform appropriately for their intended purpose can be both
challenging and resource intensive.
By using a pro-active, quality-by-design (QbD) approach, it is possible...
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Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Demonstrating that these methods consistently perform appropriately for their intended purpose can be both challenging and resource intensive. By using a pro-active, quality-by-design (QbD) approach, it is possible to design better methods, understand the strengths, weaknesses and capabilities of those method and to perform validation exercises in a scientifically rational way that will maximize success and minimize overall resource consumption. This is especially true for the method transfer process, where many examples of tremendous complication can be cited due to inadequacy in method design and development, and due to inappropriate design of method transfer protocols. This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods. By using a lifecycle approach, methods are more likely to meet their int
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From Tim Linen
Having a plan for gathering and compiling appropriate sterility assurance
documentation to be included in a global marketing application is essential for
injectable drug products.
In this session we will provide an overview of current
regulatory guidance and compendial requirements associated with sterilization
validation and control...
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Having a plan for gathering and compiling appropriate sterility assurance documentation to be included in a global marketing application is essential for injectable drug products. In this session we will provide an overview of current regulatory guidance and compendial requirements associated with sterilization validation and control of microbial quality. While guidance on overall content is readily available, a lack of understanding of specifically what information is needed and how to present it could result in regulatory questions, delay of approval, and costly repeats. This webinar will review what information is needed, what level of detail is included, and how to present the documentation in CTD format. Attendance cost: 199$ Event organizer: ComplianceOnline More Information about the Webinar: Submission Documentation for Sterilization Process Validation at http://itevent. net/submission-documentation-forsterilization-process-validation About ITEvent: At ITEVENT. NET we colle
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From Tim Linen
Reusable medical devices are receiving more and more scrutiny from regulatory
agencies both in the United States and internationally.
Sometimes it seems that the
requirements for an acceptable cleaning validation are changing on a daily basis.
Knowing the latest expectations is critical for a manufacturer so that they can
reduce the...
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Reusable medical devices are receiving more and more scrutiny from regulatory agencies both in the United States and internationally. Sometimes it seems that the requirements for an acceptable cleaning validation are changing on a daily basis. Knowing the latest expectations is critical for a manufacturer so that they can reduce the likelihood that their submission will not be accepted and require additional testing or worst case that it will need to be repeated. This presentation will address the most current expectations for cleaning validations of reusable medical devices that are performed in support of the instructions in the instruction for use (IFU). It will include both manual and automated cleaning processes as well information on how to choose test soils, markers for challenging cleaning and the acceptance criteria to use to establish effective cleaning. Attendance cost: 249$ Event organizer: ComplianceOnline Get more information and register for the Designing an effecti
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From Tim Linen
Medical products are more complicated and have greater challenges for sterilization
process than ever before.
These products might include tissue-based products,
combination products, devices with drug coatings, devices with batteries or
equipped with integrated software, circuits or computer chips.
Each of these present their own...
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Medical products are more complicated and have greater challenges for sterilization process than ever before. These products might include tissue-based products, combination products, devices with drug coatings, devices with batteries or equipped with integrated software, circuits or computer chips. Each of these present their own challenges for sterilization starting with selecting a compatible process to developing the validation strategy and meeting the regulatory requirements for ensuring that the sterilization process is adequate for the medical product. Making a mistake can be costly not only in immediate costs but also in project delays and potentially in regulatory approval. This presentation will review various sterilization processes and their general compatibility to various types of challenging medical products as well as some of the challenges that each of the various sterilization processes might present. In addition the methods that are available for validation will
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From Tim Linen
United States
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