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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: 06/28/2012 7:00 am
End: 06/28/2012 1:00 pm
This 6-hr training will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems. Why Should You Attend: This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control. It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA. Finally, and perhaps most importantly, attendees will learn how to institute simple sampling, monitoring and microbial control levels that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes. In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this invaluable training as well as the tips, tricks, and kernels of wisdom that this all-day webinar will give you. Start: 06/28/2012 8:00 am
Delivering security and compliance services can be a time consuming, difficult-to-manage process for MSP´s, MSSP´s and anyone else offering these services. Automation of these processes can speed engagements, simplify management, deliver higher value to end users and allow you to focus on growing your practice. Join eGestalt for a free webinar where we will show you how SecureGRC can help you do this with some of its exciting new features. Place - Santa Clara, California. This Webinar has been exclusively designed to address the below topics and help you understand: * Fully customizable, Web-based assessments Start: 06/28/2012 8:00 am
Course Description: Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at FDA nearly twice a month negotiating 510(k)/IDE/PMA issues for his clients. He will teach you the basics and advanced knowledge of the 510(k) program. He will also provide insights in what FDA looks for in 510(k) submission and common mistakes companies make in drafting 510(k)s. This will include insights and commentary on CDRH’s new proposals for the 510(k) program. He will also discuss the plusses and minuses of pre-IDE meetings and how to approach them. Mr. DuVal will address when and how to appeal adverse 510(k) decisions, whether it be an NSE decision or an Additional Information letter, learned in the trenches with FDA. This will include a workshop in which participants will be given hypotheticals to work on in small groups and share with the entire group the position they would take in an FDA appeal meeting. On day two Mr. DuVal will spend a half day focusing on the promotional side of marketing a 510(k) starting with the analysis of how to take to market with a general intended use statement and specific uses (indications) to which the device may be put. He will cover FDA’s “General/Specific Intended Use” Guidance document and discuss how FDA approaches the interpretation of it using real examples. He will also share ideas for e-clearance/pre-approval communications, as well as the promotional issues companies face post-approval, including FDA’s enforcement activities with respect to the promotion of general versus specific uses. This will also include a workshop where the participants will again work in small groups to construct a promotional plan for a fictional medical device. Start: 06/28/2012 10:00 am
End: 06/28/2012 11:00 am
This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S. Why Should You Attend: The rapid development of cell-based and related biological therapies for use in veterinary medicine has provided exciting new options for the safe and effective treatment of common veterinary diseases and conditions such as osteoarthritis, tendon strain injuries, suspensory desmitis, congestive heart failure and other commonly diagnosed diseases and injuries. FDA’s Center for Veterinary Medicine (“CVM”) asserts primary and exclusive regulatory jurisdiction over veterinary regenerative products and their future commercialization in the U.S. Under CVM’s proposed regulatory approach, a veterinary regenerative product exceeding a hypothetical veterinary equivalent standard will be treated as a drug requiring FDA review and approval prior to marketing and sale. Areas Covered in the Seminar: - Who regulates veterinary cellular and tissue products; and biotherapeutic products intended for commercialization. Start: 06/28/2012 10:00 am
End: 06/28/2012 11:30 am
Today, more than ever, the need to investigate and track quality issues is critical for the biopharmaceutical industry. The pressures that organizations are facing come from variety of sources: the increasingly regulations, both domestic and international, the stagnant economy, ever increasing competition, a greater public awareness, and greater demand for high quality medicines. In view of these challenges, the need to effectively investigate and track non-conformances becomes crucial for the survival of any company. With a Today, more than ever, the need to investigate and track quality issues is critical for the biopharmaceutical industry. The pressures that organizations are facing come from variety of sources: the increasingly regulations, both domestic and international, the stagnant economy, ever increasing competition, a greater public awareness, and greater demand for high quality medicines. In view of these challenges, the need to effectively investigate and track non-conformances becomes crucial for the survival of any company. With an effective investigative process and a healthy CAPA system, successful organization are able to minimize their regulatory profiles and avoid costly recalls. Why should you attend : This webinar will highlight strategies to create a robust system of reporting and investigating deviations and other non-conforming events as part of an effective quality management system, as well as understand the regulatory requirements of corrective and preventive action system (CAPA) Webinar Includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 90 Minutes Live Presentation Areas Covered in the Session: • Regulatory Requirements for CAPA Who will benefit: (Titles) Directors, Managers, professionals, technicians and general staff with responsibility for the following areas: Quality Assurance Quality Control Manufacturing and Maintenance. Regulatory Titles About Speaker Henry Urbach is a Management Consultant, Founder and President of GMP TDC LLC, a training, development and consulting company that caters to pharmaceutical and biotechnology industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in Training, QA, and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of remediation , and developing an environmental monitoring training program. He is a dynamic speaker specializing in FDA and ICH compliance, quality systems, and aseptic and environmental monitoring techniques. Henry is a founder and President of GMP Training, Development and Consulting LLC (GMP TDC), a New York-based consulting organization serving Life Sciences industries. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP Training and Education Association (GMP TEA) Start: 06/28/2012 10:00 am
End: 06/28/2012 11:00 am
This webinar will cover how to develop and implement a formal program on telecommuting for companies who are considering it and how to review and formalize current practices for companies who already have a program. Why Should You Attend: More and more companies are allowing employees to perform their work from a remote worksite ranging from an occasional occurrence to a regular full-time schedule. This webinar contains an overview of how to develop a policy, who or what positions would be eligible, alternative work arrangements, the approval process, rules of operation, compensation and eligible expenses, equipment considerations and support, and effective communication practices. We will cover the business case for telecommuting as well as the advantages and disadvantages. This session will also cover how to develop a proposal to adopt either a full telecommuting plan or hybrid and how to measure, justify and communicate results. Areas Covered in the Seminar:
Start: 06/28/2012 2:00 pm
End: 06/28/2012 2:00 pm
Click the link below to register for this free event
Host Jeff Werlwas Start: 06/28/2012 2:00 pm
End: 06/28/2012 3:00 pm
Indoor Air Quality is easily compromised by a variety of factors and can affect human health and well-being. Attend this webinar to find out more about Indoor Air Pollutants such as • Chemicals and VOCs The webinar will explore simple steps to improve indoor air quality in homes, buildings and small businesses, provide an overview of popular air filtration technologies and go over important considerations when it comes to air purifiers. Register now to reserve your seat for this free webinar. (Other dates and times may be available; for more information, e-mail michelle@airqualityacademy.org) About Air Quality Academy The Air Quality Academy is a free and comprehensive resource to distribute information, solutions and practical guidance related to indoor air quality concerns. Air Quality Academy offers complimentary webinars to promote practical solutions to IAQ concerns and support preventative maintenance combined with a rational approach to avoid common air quality problems. For more information, please visit www.airqualityacademy.org Start: 06/28/2012 2:00 pm
End: 06/28/2012 3:00 pm
While most clinical research professionals are familiar with US pharmaceutical regulations, many have no experience with regulated research involving medical devices, or their experience is primarily related to studies conducted outside the United States (OUS). As globalization of research increases and more device/drug and device/biologic combination products are introduced into the market, each of us is more likely to become involved in clinical research of medical devices. Device clinical research activities must comply with many of the same regulations as pharmaceutical products, but there are some notable differences. The regulatory similarities and key differences, such as phases of study, classes of risk, adverse experience and reimbursement practices will be presented. Regulation of medical device approvals in the US differs from that of pharmaceutical products. Many clinical research professionals are not familiar with device research requirements in the US. As more combination products (device/drug, device/biologic) are developed, we will all need to become more familiar with the differences between drug and device research to ensure we are compliant with the regulatory requirements specific to devices. Why should you Attend: In the US, clinical development of both devices and drugs are regulated by the FDA. While there are many similarities between regulatory requirements for the two types of products, there are also some important differences. - List at least three differences between the clinical development and approval of drugs versus devices in the US. -Identify the US regulations that apply to both drug and device studies. - Recognize differing product development and product reimbursement practices of drugs and devices. Areas Covered in the Session: We will review some key differences between the pharmaceutical and device industries, regulatory requirements common to drug and device clinical studies and illustrate some important differences such as reimbursement issues specific to device trials. Who will benefit: - Clinical research manages About Speaker Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) located in central NY State, USA. She has been involved in regulated research since 1997 and specializes in medical device monitoring and project management; GCP, vendor and third party auditing as well as training on US regulated research and Good Clinical Practice. Ms. Guest is an active member of the Association of Clinical Research Professionals (ACRP) and is a regular speaker at their local events and global conferences. She has also presented at a number of other industry-related events and enjoys sharing her expertise with colleagues in the clinical research arena. Ms. Guest has maintained her status as an ACRP Certified Clinical Research Associate since April of 2002. She is also recognized by the Society of Quality Assurance as a Registered Quality Assurance Professional - Good Clinical Practices (RQAP-GCP),having successfully passed the first exam for this designation offered by SQA in April 2007. Start: 06/28/2012 2:00 pm
End: 06/28/2012 3:00 pm
While most clinical research professionals are familiar with US pharmaceutical regulations, many have no experience with regulated research involving medical devices, or their experience is primarily related to studies conducted outside the United States (OUS). As globalization of research increases and more device/drug and device/biologic combination products are introduced into the market, each of us is more likely to become involved in clinical research of medical devices. Device clinical research activities must comply with many of the same regulations as pharmaceutical products, but there are some notable differences. The regulatory similarities and key differences, such as phases of study, classes of risk, adverse experience and reimbursement practices will be presented. Regulation of medical device approvals in the US differs from that of pharmaceutical products. Many clinical research professionals are not familiar with device research requirements in the US. As more combination products (device/drug, device/biologic) are developed, we will all need to become more familiar with the differences between drug and device research to ensure we are compliant with the regulatory requirements specific to devices. Why should you Attend: In the US, clinical development of both devices and drugs are regulated by the FDA. While there are many similarities between regulatory requirements for the two types of products, there are also some important differences. - List at least three differences between the clinical development and approval of drugs versus devices in the US. -Identify the US regulations that apply to both drug and device studies. - Recognize differing product development and product reimbursement practices of drugs and devices. Areas Covered in the Session: We will review some key differences between the pharmaceutical and device industries, regulatory requirements common to drug and device clinical studies and illustrate some important differences such as reimbursement issues specific to device trials. Who will benefit: - Clinical research manages About Speaker Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) located in central NY State, USA. She has been involved in regulated research since 1997 and specializes in medical device monitoring and project management; GCP, vendor and third party auditing as well as training on US regulated research and Good Clinical Practice. Ms. Guest is an active member of the Association of Clinical Research Professionals (ACRP) and is a regular speaker at their local events and global conferences. She has also presented at a number of other industry-related events and enjoys sharing her expertise with colleagues in the clinical research arena. Ms. Guest has maintained her status as an ACRP Certified Clinical Research Associate since April of 2002. She is also recognized by the Society of Quality Assurance as a Registered Quality Assurance Professional - Good Clinical Practices (RQAP-GCP),having successfully passed the first exam for this designation offered by SQA in April 2007. Start: 06/28/2012 5:00 pm
How to effectively manage ITIL Compliant IT Services for Customers.This webinar aims at sharing Kovair’s experience in setting up 100% web-based ITSM Solution for integrating and automating various ITIL v3 process areas on June 28, 2012, 5:00 PM IST | ||
