Public Health

Overview: Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods. Why should you Attend: Accurate prediction of product shelf-life performance is critical to your success. "Do it right the first time", choose the most functional and resistant materials for your product instead of going through the post launch cycle of panic driven product revisions. Also learn the basis for choosing the optimum accelerated test design based on materials, product design, processing, and functional product requirements. Learn how to "think like a molecule" and plan and design around "aging" induced changes in materials qualities (brittleness, color, and odor) that cut short your product's long term functionality.

Everyone knows we must focus on safety in healthcare delivery. Attending this session will help you better understand how the built environment impacts safety and is integrated with operational efficiencies.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/LEAN-HEALTHCARE-FACILITY-DESIGN-501911/DECEMBER-2016-ES-TRAININGREGISTRY

Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.

Overview: Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect. The medical device professional will often take the lead role in overseeing all aspects of regulatory & quality compliance, including CMC aspects, particularly when the "primary mode of action" relates to the device component.

Overview: The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration. The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines. The CDRH director recently retired under a cloud of complaints from center scientists about device approvals being too friendly to manufacturers. More inspectors are taking to the field to attack the backlog of inspections, and FDA is once again pushing third party inspections as another strategy to reduce backlog. The commissioner is speaking about returning to the mission of the agency, protecting the public health, All of these changes bring uncertainty to device approvals and the ability of manufacturers to keep products on the market.

Overview: This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.

Overview: Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation. Areas Covered in the Session: FDA and International GLP regulations: 21 CFR Part 58, OECD Objectives and concepts of GLP's Special organizational requirements Responsibilities: Management, Study director, QA, analysts SOP requirements: type, formats and enforcement

Overview: CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are. Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/2aWYZbK Twitter Follow us – https://twitter.com/compliance4all Facebook Like us – https://www.facebook.com/Compliance4all

Overview: This webinar explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization. Lyophilization is complex, and this seminar will break the process down so that it can be more easily understood. The important aspects of how FDA inspects and regulates the lyophilization process, equipment, and controls will be discussed. The science and art of how to develop lyophilization cycles will be discussed. Lyophilization controls, including computer controls and validation will be explored. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/2aVN8o0 Twitter Follow us – https://twitter.com/compliance4all Facebook Like us – https://www.facebook.com/Compliance4all

Accredited self-paced online Medical Coding training. This course covers ICD-10, HCPCS, and CPT and is approved by the AAPC. Students can enroll at any time and complete the course at their pace. Begin learning Medical Coding today!

Overview: The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k). Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not. The decision has to be made by the manufacturer, subject to review by the FDA inspector. This talk will provide quality and regulatory personnel the means to help to the company make the right decision and document it fully, before the change goes through.

Overview: FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 24 months FDA issued more than 30 warning letters with citations Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at and what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

Overview: Learn about the issues and how can they be addressed. Understand what responsibilities each of us must adopt to help ensure that our food supply is safe. Why should you Attend: This webinar will address the complexity of defining safe food and examine the factors that impact on microbiological food safety. We will look at the changing nature of foodborne/food transmitted pathogens and the influence of demographics and geography on the changing landscape. The webinar will also discuss roles and responsibilities for mitigating food contamination and foodborne illness.

Overview: Since the year 2000 there has been an increasing trend of registered clinical studies from approximately 4,000 in 2000 to 160,000 in 2014. In 2014 Forbes Magazine reported that the FDA had approved 44 drugs the highest in 18 years. As innovation and new technological approaches are applied to the discovery of novel molecules, the number of studies will continue to increase to meet the areas of unmet medical needs and especially rare diseases. Clinical Trial.gov currently list 193,510 studies in 50 states and in 190 countries. Given the enormity of studies, the many clinical sites and the number of clinical professionals involved in these studies, guidelines and regulations have to be in place to direct the daily monitoring of the studies, training of staff and data management.

The course will cover all aspects of overpayment, identification of overpayment on the organizations part, overpayment and demand bills from Medicare. What to do if you believe the over payment demand is in error.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MEDICARE-OVERPAYMENTS-WHAT-DO-YOU-WHEN-DO-YOU-501449/JUNE-2016-ES-TRAININGREGISTRY

CMS recently finalized a number of significant changes to the Stark Law for the 2016 calendar year. Now that these changes have gone into effect, health care organizations should be monitoring and auditing their existing arrangements to ensure they are compliant with Stark's technical requirements and key tenets of defensibilityPrice:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/PHYSICIAN-LEASES-NEW-2016-STARK-RULES-501426/JUNE-2016-ES-TRAININGREGISTRY

The FDA guidance has rapidly increased the use of electronic data capture. Pharma and Investigators seek to minimize the burden of documentation in the conduct of clinical trials. Pursuance of that goal without focus on inspectional compliance can incur a failed regulatory inspection.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ELECTRONIC-INTEGRITY-GXP-ENVIRONMENT-501420/JUNE-2016-ES-TRAININGREGISTRY

This webinar will review and provide a practical approach to investigating and reporting complaints of adverse reactions related to HCT/Ps. The FDA has implemented a risk-based approach to the regulation under 21 CFR Part 1271 for HCT/Ps to prevent the introduction, transmission and spread of communicable disease.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/INVESTIGATING-REPORTING-CELLS-TISSUES-HCT-PS-501482/JUNE-2016-ES-TRAININGREGISTRY

Overview: Consider a DME (Durable Medical Equipment) Profit Center for your practice. Your Practice can develop a new revenue stream from your existing patient base by providing braces & pain management solutions right from your own office! Fully compliant with federal and state regulations. You're already creating DME revenue - Why not keep it for your practice? Increased Revenue & Profit For Your Practice! Better Service & Outcomes For Your Patients! From Your Existing Patient Base!

Overview: This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device. Inadequate validation of software continues to be a leading component of device warning letters. Problems mainly include 1) Software that is a component of the manufacturing process (not necessarily a medical device, but like all device class II and III, manufacturing elements, subject to QSR’s), or 2) software that is a component or accessory of some Class III or Class II medical device (Itself a medical device, per FDA guidance).