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: 07/11/2012 7:10 am
Overview: 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, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written down, it didn't happen. As well, if it isn’t written down clearly, it didn’t happen either. GMP compliance (21CFR, Part 211) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. Why you should attend: The Learning Objectives of this presentation include: Who Will Benefit: Start: 07/11/2012 10:00 am
End: 07/11/2012 11:00 am
This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation. Why Should You Attend: Many companies struggle with understanding what FDA, MHRA, EU and other Ministries of Health want to see regarding software validation.This presentation will review the FDA validation process, the GAMP® software validation model, and the process defined in GAMP® 5 as it applies to FDA software validation. The attendee should leave the presentation confident in their ability to understand and apply the GAMP® 5 process. - FDA inspectors are now being trained to evaluate software validation practices. Start: 07/11/2012 10:00 am
Join us Wednesday, July 11, 2012 from10:00 to11:00 a.m. EST for an interactive webinar. During this webinar you will have a chance to learn how to protect and license your products, and meet the evolving needs of your customers through an extensive array of licensing models and features. Be sure to register at https://www4.gotomeeting.com/register/854141303! Start: 07/11/2012 12:00 pm
This webinar is designed to educate participants about art therapy and provide practical skills for effective assessment and intervention with clients experiencing symptoms of anxiety. Full Description: clients experiencing symptoms of anxiety. Demonstrations of art therapy techniques will advance the participants’ understanding of the bio psychosocial perspective of many of the disorders that fall under the category of “anxiety,” including phobias, PTSD, panic, as well as sleeping and eating disorders. Significant attention will be paid to treatment interventions with numerous opportunities for hands-on art-based techniques. Course Includes: What You Will Learn: Sleep Disorders, and Panic Attacks Your Presenter: Therapist and Mental Health Counselor and is currently in private practice in Los Angeles, California. Ms. Hayes developed the art therapy program at the Rhode Island School of Design. For the past 15 years, Ms. Hayes has worked in numerous psychiatric settings. Currently, her focus includes families, couples, adults, and children struggling with mood and anxiety disorders, addiction, eating disorders, abuse, and grief- related issues. Ms. Hayes has an undergraduate degree in Fine Arts from Parsons School of Design in New York City and a graduate degree in Marriage and Family Therapy and Art Therapy from Notre Dame de Namur University in Belmont, California. For more information about Ms. Hayes, please visit her website at: www.hayesarttherapy.com. Disclaimer: attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event. Technical requirements: time, you can setup prior to the meeting by following this link: https://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php Who Should Attend: Pediatricians, Physicians, Art Therapists, Pastoral Counselors, Guidance Counselors, Youth Pastors, Youth Counselors, Educators Start: 07/11/2012 12:30 pm
End: 07/11/2012 2:06 pm
Successful companies in leading sectors tend to exhibit a common characteristic – they employ supply chains that are integrated in terms of both physical flow of materials and information. This allows them to build cultures and quality systems that continuously improve the ways they do business and deliver value to their customers. The pharmaceutical industry, for reasons which are made clear in the webinar, has not placed the same importance on the supply chain and is now suffering the consequences. The main thrust of the session will be towards understanding what those successful companies (from industries such as semiconductor, automotives and aerospace) did to achieve integrated supply chains, how they continue to do it and what benefits they derive. It starts with the design & development stage, where supply chain foundations are laid and explores how supply chain management (SCM) competencies can and should be applied at this critical stage. Then it examines how SCM must permeate the organization for the full life-cycle of the product. The modernization initiates from FDA and ICH are translated into the language on modern production systems (such as Toyota Production System - TPS) and a plan for moving from what the Lean experts call a ‘process village’ to a value stream alignment is outlined. Finally, the session will pull together a cohesive account of the necessary cultural and organizational changes that must take place at both industry and company level to ensure sustainable supply chain performance improvement; this will be perfect ammunition to help talk to others within your organization to start a dialogue for change………. Areas Covered in the Session: · What the regulators (FDA/EMA/MHRA) are demanding of industry to increase supply chain integrity and control. · The role of drug development (CMC) as a critical enabler of supply chain performance · The power of supply chain management (SCM) when it integrates strategic procurement, production and inventory control, transportation and storage, information systems and improvement methodologies. · How to build, manage and perfect the supply chain using Lean and Systems Thinking · What you need to do the convince senior management of the need for change · Driving meaningful change for the better (Kaizen) Webinar Includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 90 Minutes Live Presentation Who will benefit: (Titles) · Research chemistry and biochemistry Why should you attend? The Pharmaceutical supply chain is in trouble as never before. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees (eg the Health, Education, Labor and Pensions Senate Committee –HELP) have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Companies such as J & J and Novartis are also writing off hundreds of millions worth of cost due to much publicized manufacturing issues. Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death. So what has gone wrong and how will it all pan out? We have to trace back to the 1970’s, when outsourcing of manufacture and distribution began in earnest; this was followed by a move towards off-shoring of key intermediates, APIs and even drug product. The result is we now have the most dis-integrated supply chain any industry sector has ever known. Without urgent remediation at the grass roots level, things are set to stay the same. This webinar will provide attendees with a clear understanding of where the issues lay, and provide a structured road map to steer a path to move your supply chain to a new level of performance in terms of quality, cost and performance. This is achieved by exploring ways of working that move away from the mass production paradigm towards patient focused value streams About Speaker Hedley Rees is a practising consultant, coach and trainer, helping healthcare companies build, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company, Biotech PharmaFlow Ltd, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 – Q10.Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley & Sons, Hoboken, New Jersey. Start: 07/11/2012 4:00 pm
End: 07/11/2012 5:15 pm
This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and provide recommendations and tools for effective implementation. Why Should You Attend: Compendial methods such as USP and EP standards are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example, 21 CFR 211.194 (a) states: The suitability of all testing methods used shall be verified under actual conditions of use. However, the FDA does not give any further guidance on what, when and how. And the first revision of USP <1226> did not have specific recommendations. But FDA inspectors go out and write 483's and warning letters related to <1226>. Now USP has announced to come out with a new revision using the risk based approach for the type and extend of testing. This webinar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation. Hand-Outs: For easy implementation, attendees will receive
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days. | ||
