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.
The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003.Next, the speaker will provide an overview of the updated standard.
Why should you Attend:
This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.
Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.
In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS.
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FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain.
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This seminar provides Professionals working in this area with
A thorough understanding of the complexities involved
All the relevant regulations and guidelines
Real life examples of how to register and maintain various types of combination products
Interfaces: Change Management and LCM
Compliant safety reporting for combination products
Documentation requirements and interfacing
MVP Seminars LLC, is a leading nationwide provider of
business training seminars at affordable
prices, with top-notch providers.
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510-558-3495. Largest family run training business in
Changing state laws have resulted in marijuana use being decriminalized, approved for medical use, and outright legalized. Of course marijuana use remains illegal under federal law. These conflicting changes have led to direct legal claims against employers, as well as challenges under unemployment, workers' compensation and safety programs.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link http://onlinecompliancepanel.com/webinar/MEDICAL-MARIJUANA-WORKPLACE-501928/DECEMBER-2016-ES-TRAININGREGISTRY
A busy doctor is an easy target for embezzlement and in a down economy; a doctor may be even more at risk. The importance of educational, credit checks and drug screening will also be covered as well as practice policies and procedures implementation. Savvy embezzlers can fool even the most experienced employers, so learn how to protect yourself. Real life case examples will be discussed. "Tips to Protect Your Practice from Embezzlement" was published in The Journal of Medical Practice Management.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link http://onlinecompliancepanel.com/webinar/EMBEZZLEMENT-MEDICAL-PRACTICE-504573/MARCH-2017-ES-TRAININGREGISTRY
This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in the regulatory environment is reviewed and the role of conditional approval and PASS and PAES studies is also discussed.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link http://onlinecompliancepanel.com/webinar/DRUG-SAFETY-PHARMACOVIGILANCE-504550/MARCH-2017-ES-TRAININGREGISTRY
This webinar, presented by a leading regulatory affairs expert with successful BTDs, discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The session will highlight key regulatory requirements, dos and don'ts, common areas of concern, and trouble-shooting BTD requests using case studies and examples from the presenter's vast experience helping companies big and small in successfully applying for a BTD.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link http://onlinecompliancepanel.com/webinar/BREAKTHROUGH-THERAPY-DESIGNATION-504525/MARCH-2017-ES-TRAININGREGISTRY
The basic principles of human factors engineering can be applied universally to improve the safety and usability of any medical product. However, each product still has its own unique considerations. Combination products or medical devices that include a drug or biological components, can introduce concerns that do not necessarily apply to non-drug devices. To ensure that product design is optimized, it is important to take a product's specific needs into consideration. This course describes how to apply human factors principles to the design and development of combination products while also maximizing safety and meeting the expectations of the FDA..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/HUMAN-FACTORS-EVALUATIONS-COMBINATION-PRODUCTS-502265/AUGUST-2017-ES-TRAININGREGISTRY
This webinar will cover the new law on confidentiality of substance use disorder patient records under 42 CFR Part 2. This law was previously known as the confidentiality of drug abuse and alcohol abuse records. The new law was effective in 2017. Anyone or any facility that is subject to these requirements needs to attend this webinar.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/NEW-FEDERAL-LAW-42-CFR-PART-2-503438/AUGUST-2017-ES-TRAININGREGISTRY
The ADA has made a huge difference in the elimination of discrimination against people with disabilities in the workplace. But what about employees who abuse alcohol or drugs? How can an employer manage drug and alcohol abuse within the workforce? This webinar will explore the recent amendments to the ADA and how they impact management of employees with addictions. Participants will learn practical strategies to comply with the ADA while protecting the workplace from the negative impact of drug and alcohol abuse of its employees..Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/ADA-ALCOHOLISM-ADDICTION-507814/SEPTEMBER-2017-ES-TRAININGREGISTRY
We all have medical issues from time to time and sometime we need something over the counter or stronger that is prescribed by a physician. Though, the use of prescription drug is quite legal, the warning on the label always mentions not to operate heavy machinery while taking such medications. The risks are loud and clear. So, when can you as an employer regulate something that might be completely legal? When can an employer require an employee to disclose his/her medications and what an employer needs to do?Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://onlinecompliancepanel.com/webinar/MEDICAL-MARIJUANA-AND-OTHER-PRESCRIPTIONS-508435/OCTOBER-2017-ES-TRAININGREGISTRY
The goal of this course is to help the learner to understand the laws that apply to filling prescriptions for animals, and to provide resources for finding answers to veterinary pharmacy situations. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://onlinecompliancepanel.com/webinar/VETERINARY-PHARMACYY-LAW-AND-OCCUPATIONAL-503173/NOVEMBER-2017-ES-TRAININGREGISTRY
This webinar will examine the implications of the Sunshine Act for healthcare providers and life science companies.
Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Sunshine-Act-Reporting-Clarification-for-Clinical-Research-508714/MAY-2018-ES-TRAININGREGISTRY