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: 07/19/2012 7:10 am
Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits. Areas Covered in the Session: The employees who will benefit include: Start: 07/19/2012 9:00 am
Course Description :- Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different than the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency. This interactive two-day course will help you comprehensively understand details of the MDD and implement its requirements. Attendees will learn how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it. During the course, participants will have exercises that apply the principles and help solidify learning. The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards. Course Objectives :-
Start: 07/19/2012 10:00 am
End: 07/19/2012 11:00 am
Overview: Regulatory compliance requirements for CFR 21 Part 11/Annex 11 (also known as ERES) have undergone several revisions since its inception during the late 1990s. While the agencies have endeared themselves to the industry by adopting a flexible audit approach for ERES, they are increasingly requiring companies to comply with the regulations. Increased number of citations and the recently announced "tag along" audit approach is a gentle reminder of things to come by way of stricter enforcement of Part 11/Annex 11. It is critical that the industry becomes familiar with the intricacies of the regulation so as to ensure that audits of their systems in this area are citation free. Why should you attend: It has been close to a decade since the US FDA published their Scope and Application guidance for CFR 21 Part 11. Since then, there have been numerous meetings between industry experts and FDA. These meeting addressed issues stemming from implementing the Part 11 regulations. In 2010 the FDA undertook a review of the inspection status of Part 11. The returned to the industry to reaffirm their audit approach to ensure that their Scope and Application guidance of 2003 will remain in effect and that their auditors would continue to audit for and enforce Part 11 in certain specific areas. Such audits would be known as "tag along audits" with specific audit focus on certain very critical aspects of good electronic documentation to ensure the authenticity and integrity of their data. Such audits are already in progress and a significant number of citations have been issued in the past 6 months. Attend the webinar to familiarize yourself with this new audit approach for Part 11 and thereby increase your chances for a successful audit. The webinar has been designed to address the subtleties of Part 11 regulations with reference to the items that regulatory agencies are focusing on during their "tag along audit" strategy. Specifically, the 483s and Warning Letters pertaining to such audits will be examined for trends and strategies that your company should adopt will be discussed. Areas Covered in the Session: He has more than 35 years of hands on industry experience in directing the implementation, validation and obtaining “fit for use” certification of large biopharmaceutical manufacturing automation and IT systems. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11. He has a very broad experience in facilitating QRM sessions for large US companies and has provided them with consultant oversight to establish their Quality Risk Management plans. His training sessions are unique in that he combines his field experience to explain the intricacies of applying the regulations. Such an approach of blending theory with practical applications has provided his trainees the necessary skills to lead regulatory efforts in their respective organizations Price List: Start: 07/19/2012 10:00 am
End: 07/19/2012 11:30 am
This 90-minute webinar provide you a comprehensive understanding of HR policies that small companies need to have, information on the number of employees you can have before you must have these policies in place, and save you from penalties and fines. Why Should You Attend: Any business, even smaller units, needs to have HR policies. Most business have someone employed or a vendor to handle government requirements that have to do with finances. But, most often they fail to have anyone managing employee/ HR policies. Failure to do so can result in liabilities that can cost your business enormous sums of money in court settlements.
This 90-minute webinar is intended to provide you a comprehensive understanding of these policies, information on the number of employees you can have before you must have these policies in place, and save you from penalties and fines. Learning Objectives: Understanding the threshold number of employees before various written human resource policies are required by an organization. Start: 07/19/2012 10:00 am
End: 07/19/2012 1:00 pm
This 3-hr virtual seminar will help you understand the requirements of OSHA PSM and NEP audit topics that have been interpreted and reviewed in the compliance guidelines as they might apply to an anhydrous ammonia refrigeration plant. Why Should You Attend: Effective November 2011 Federal OSHA has embarked on a new National Emphasis Program (NEP). The NEP is focusing on Process Safety Management (PSM) covered chemical plant operations specifically including anhydrous ammonia refrigeration facilities. OSHA has a considerable body of written interpretations and compliance guidelines focused on assisting employers in understanding the NEP as well as PSM (29 CFR1910.119) requirements. This 3-hr virtual seminar will examine the basics of implementing Federal OSHA PSM requirements in anhydrous ammonia refrigeration facilities. The session will also survey priority audit topics of OSHA National Emphasis Program (NEP) audits. Key topics include review of OSHA formal letters of interpretation and how they affect owners and operators of covered anhydrous ammonia refrigeration processes. The course will also specifically examine the current OSHA PSM compliance directive (CPL-02-02-045) as well as the recent OSHA covered process National Emphasis Program (NEP) compliance directive (CPL-03-00-014). Start: 07/19/2012 10:00 am
End: 07/19/2012 11:00 am
Why Should You Attend: 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. Areas Covered in the Seminar: * Cleaning validation design - automated cleaning. Start: 07/19/2012 10:00 am
End: 07/19/2012 11:00 am
Why Should You Attend: The FDA recently held hearings addressing drug companies' use of social media and other online platforms to advertise. FDA also released a guidance document about manufacturers’ obligation regarding off-label information available about their products. Another guidance document about use of social media in marketing is expected soon. In addition, FDA issued several letters to manufacturers indicating the rules for using social media. But there is still much confusion among FDA regulated companies how to use social media for marketing effectively and still be compliant with regulations. Areas Covered in the Seminar: - How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media. Start: 07/19/2012 10:00 am
End: 07/19/2012 10:00 am
Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits. Areas Covered in the Session: Price List: Start: 07/19/2012 10:00 am
End: 07/19/2012 11:30 am
Description Consequences of not adequately managing cleanrooms are many, however the most critical is causing harm to the patient. This session will start with a discussion on designing the cleanroom per product requirements. Additionally, you will understand the risk posed by inappropriate flows which can affect cleanroom environment. You will learn how to qualify the cleanroom by objectively evaluating the functioning capabilities of the HVAC system to meet pre-determined criteria - classification of cleanroom, acceptable levels of total particulate counts, viable particulate count, air flow rates, difference pressure, temperature, and humidity. The presenter will provide a scientific risk based approach to cleanroom management as a sure way to ensure production of contamination free products that are safe for human use. Learning Objectives: The objective of this session is to create an awareness about cleanroom management among those who work in cleanrooms so that the productivity can be increased by reducing contamination. Areas Covered in the Seminar: Discussion on facility design as the first step. Start: 07/19/2012 10:00 am
End: 07/19/2012 11:00 am
Overview: IEC62304 is a internationally recognized software lifecycle standard. The risk dependent activities and documentation requirements necessary for compliance with this document will be explained. Questions like: Why should you attend: This webinar will explain basic design control concepts and the criticality dependent requirements for software development. Software specification, architectures and resulting design documentation will be discussed, as well as practical tips on how to streamline the development process and minimize the regulatory burden. Areas Covered in the Session: Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms. Start: 07/19/2012 12:00 pm
End: 07/19/2012 1:15 pm
Can you really find new clients in July and August - while still having time to enjoy the summer? You bet! Discover how to network in unusual places, make the most of chance encounters, and make a bigger impact with a lot less work! Leverage the summer slow-down to get a leg up in winning the marketing game - and have more clients come September. | ||
