Project Management Industry Training

This webinar will present a unique perspective on risks associated with extractables, leachables & elemental impurities (ELEI) in cGMP manufacturing of pharmaceutical, biologic and medical device products. The webinar will start with a definitional review of the topic and then present the current FDA perspective on impurities of these types in product. After that introduction, the instructor will present quality and compliance considerations related to ELEI.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/EXTRACTABLES-LEACHABLES-cGMP-MANUFACTURING-507103/JULY-2017-ES-TRAININGREGISTRY

Two audit approaches that add value to the enterprise are Integrated Operational Auditing and Business and IT Project Auditing. The auditing function in an enterprise is in a unique position to influence the integration of the enterprise from a top-down perspective. Improved operational and project performance are two areas that can significantly contribute to the enterprise bottom line.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/ADDING-VALUE-ENTERPRISE-508376/JULY-2017-ES-TRAININGREGISTRY

The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision in over a decade to the ISO 13485 Quality Management Systems standard, and the changes to the EU's Medical Device Regulation that was just approved in April 2017. All of these events have far-reaching effects on Quality Management Systems so it is critical to understand what has changed within ISO 13485:2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/workshop/QUALITY-MANAGEMENT-ISO13485-2016-504371/JULY-2017-ES-TRAININGREGISTRY

Product Reliability requirements must be satisfied like all other performance requirements prior to product launch. However, since reliability is a function of time, the methods for verifying that reliability performance has been verified differ than for most other performance characteristics. This webinar will present several approaches for verifying that reliability targets or specifications have been achieved at the desired level of confidence. Specifically, approaches using time-to-failure data to estimate reliability metrics as well as demonstration tests, where minimum reliability may be demonstrated with zero or few failures are discussed.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/DEMONSTRATING-PRODUCT-RELIABILITY-508137/JULY-2017-ES-TRAININGREGISTRY

This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/GOOD-DESIGN-HISTORY-FILE-AUDIT-506688/JULY-2017-ES-TRAININGREGISTRY

During this webinar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what "red flags" to look for that may indicate issues on site. Across the industry, companies are striving to find ways to improve operational efficiencies. Currently, over 80% of site-based documentation today is still fully paper based, with both cost and risk consequences for the entire clinical trial process.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/REINVENTING-REMOTE-MONITORING-CLINICAL-TRIAL-503276/JUNE-2017-ES-TRAININGREGISTRY

This webinar explores the components of strategic risk. Developing a common understanding and definition of strategic risk helps the participant form a comprehensive base upon which meaningful review and interaction with senior management can occur. The session introduces a new way of looking at organizational strategic risk so that Boards of Directors, Senior Managers and other organizational leaders will develop and demonstrate thoughtful process behind strategic decision making.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/RECOGNIZING-MANAGING-STRATEGIC-RISKS-508259/JUNE-2017-ES-TRAININGREGISTRY

This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/COMPLIANCE-ICH-GCP-R2-ADDENDUM-AUDITORS-505313/JUNE-2017-ES-TRAININGREGISTRY

FDA's Breakthrough Therapy, Accelerated Approval, Priority Review and Fast Track designations can reduce product approval timelines if pursued and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about what's best for your product development program.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/FDAs-EXPEDITED-DEVELOPMENT-505309/MAY-2017-ES-TRAININGREGISTRY

Dashboards and reports are a critical tool in your communication armoury. A well-designed and meaningful dashboard offers a CEO, shareholder or Project Manager a valuable insight into the Key Performance Indicators (KPI's) upon which a business or project is measured and enables them to determine the future direction of the business or project.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/USE-EXCEL-DASHBOARDS-507439/MAY-2017-ES-TRAININGREGISTRY

This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.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/COMPLIANCE-EU-REGULATION-CLINICAL-TRIALS-506624/APRIL-2017-ES-TRAININGREGISTRY

HUD has just issued new final rules and guidance on final rules which affect fair housing protections. These rules went into effect recently. These rules directly affect fair housing requirement s for owner and management agents. In this seminar, they will be explained in detail and guidance will be given in how these updates should be implemented in today’s fair housing environment considering disparate impact rulings from HUD.

In this webinar, participants will be introduced to the VFM techniques they require to permit a generalist auditor to evaluate the economy, efficiency and effectiveness of the IT function.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/AUDITING-IT-FUNCTION-504445/APRIL-2017-ES-TRAININGREGISTRY

This webinar ensures your company gets a broader perspective of how and what to do to get a quick and non-debatable or questionable approval for your 510K product. All are different so this presentation will not just be specific for a specified Medical Device that is currently being marketed and your company wants the same opportunity to produce and sell that product.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/US-FDA-MEDICAL-DEVICE-510k-508586/APRIL-2017-ES-TRAININGREGISTRY

This seminar will go into detail on the UPCS property standard guidelines as well as the Real Estate Assessment Canter (REAC) inspection process. It will contain information on the latest rules and how they are interpreted during an inspection of the property. This should be mandatory attendance for anyone involved in property management. This is an important inspection and you should learn what needs to be done in preparation for the inspection, what the rules are for correcting deficiencies and the time lines involved.

Notes to File (NTF), also known as Memo to File, are commonly used as essential documentation in sponsor and site files. Many times the content of the NTF does not serve the purpose for use or serves no purpose at all. This webinar will discuss the appropriate and inappropriate uses of NTF, the questions to ask to determine if NTF would be beneficial, and the components of a quality NTF, if being used.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/CLINICAL-TRIAL-BEST-PRACTICES-506962/FEBRUARY-2017-ES-TRAININGREGISTRY

In this webinar, you will learn the required contents of Module 3 as well as the appropriate formatting. Lifecycle management and updating requirements will be discussed, including appropriate change control and sponsor notifications. You will also gain an understanding of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections.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/DRUG-MASTER-FILES-DMFs-509436/FEBRUARY-2017-ES-TRAININGREGISTRY

This webinar will help you learn the basics of design controls for medical devices. This webinar will focus on the fundamental concept that quality cannot be inspected in--it must be designed in. We'll cover the regulations and expectations for design control. We'll discuss how design control fits into your Quality Management System. Successful integration can enhance your new product development process.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/QUALITY-DESIGN-502012/FEBRUARY-2017-ES-TRAININGREGISTRY

This webinar discusses effective Pharmaceutical Technology Transfer procedures as they are currently practices by successful pharmaceutical and biopharmaceutical firms. It introduces compliant modular approach to technology transfer projects that covers multiple disciplines including Project Management, Analytical and Microbial Quality Control, Operations, Quality Assurance Safety, Engineering, Regulatory Affairs and other relevant areas.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/PHARMA-TECHNOLOGY-TRANSFER-502023/JANUARY-2017-ES-TRAININGREGISTRY

This course covers the new technologies affecting healthcare. During this discussion, we will look at how IoT, data analysis and advanced AI is enhancing the outcomes of individuals as well as driving new engagement models outside of the traditional care environment. As the shifting payment models are driving from fee-for-service to paying for quality outcomes, the new technologies offer continuous engagement with those in most need of follow on care.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/NEW-TECHNOLOGIES-AFFECTING-HEALTHCARE-501980/DECEMBER-2016-ES-TRAININGREGISTRY