Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.
Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?
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This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.
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This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case studies and examples will be used, with theoretical information introduced only when necessary to understand an experiment. Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work.
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Classification systems differ from that of the United States or European Union in select countries
Medical devices are classified depending on their risk level
Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements
Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia
The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear.
In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy.
And Much More...
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Financial institutions know how the regulators view outsourcing. They expect that institutions will perform extensive due diligence of all third parties before entering business arrangements with them. They also expect that bankers will monitor those relationships for risks that could adversely impact the institutions operations and safety and soundness..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/SSAE-18-SERVICE-ORGANIZATION-CONTROL-REPORTS-509410/SEPTEMBER-2017-ES-TRAININGREGISTRY
The Certificate in Cybersecurity program is a suite of online courses offering information security training in Asset Security, Communications and Network Security, Identity and Access Management, Security and Risk Management, Security Assessment and Testing, Security Engineering, Security Operations, and Software Development Security.
This training program will equip attendees with basic everyday tools to keep cyber criminals at bay. The course will also emphasize the need for effective communication between team members of a financial firm.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/NAVIGATING-FINANCIAL-REGULATIONS-CYBERSECURITY-504313/AUGUST-2017-ES-TRAININGREGISTRY
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.
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. The course will include tips on how to understand FDA's thinking, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities.
This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi requirements management KPA, helps companies meet FDA's design control requirements.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/COMPLIANCE-FDAs-DESIGN-CONTROL-504040/AUGUST-2017-ES-TRAININGREGISTRY
With mobile platforms more user friendly, and with computers, tablets and smart phones becoming more powerful, we see an increase in the offering of apps. Some of these apps are specifically targeted to assist individuals in the management of their health and wellness, while other apps are targeted to healthcare providers as tools to assist in the delivery of care.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/MOBILE-MEDICAL-APPS-CYBERSECURITY-509085/AUGUST-2017-ES-TRAININGREGISTRY
This webinar focuses on the great diversity in the global arena, and the challenges that accompany communicating through different cultures: language, customs, non verbal communication, management styles. lf you are ethnocentric then you can profit from this training, because it begins the dialog of issuers like race, gender, customs, standards of business and performance in cultures like Japan, Nigeria, and the United States.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/WORLD-BEYOND-INDIVIDUAL-CULTURAL-BORDERS-507631/AUGUST-2017-ES-TRAININGREGISTRY
The Customs Trade Partnership Against Terrorism is one of the most important trade partnership programs offered to the US trade community in the last 15 years. Benefits associated with membership include expedited customs clearance and mitigation to possible CBP fines and penalties for acts of common compliance error which is now greatly enforced since the passage of the Trade Facilitation and Trade Enforcement Act of 2016.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.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/PHARMACEUTICAL-MEDICAL-DEVICE-BIOLOGICS-INDUSTRY-505657/AUGUST-2017-ES-TRAININGREGISTRY
All computer systems which store data which is used to make quality decisions or data which will be reported to the FDA must be compliant with 21 CFR 11. In laboratory situations, this includes any laboratory results used to determine quality, safety, strength, efficacy, or purity. In clinical environments, this includes all data to be reported as part of the clinical trial used to determine quality, safety, or efficacy. In manufacturing environments, this includes all decisions related to product release and product quality.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/FDA-INSPECTION-STRATEGIES-504251/AUGUST-2017-ES-TRAININGREGISTRY
The CMS released its long-awaited final rule establishing emergency preparedness requirements for healthcare providers and suppliers participating in Medicare and Medicaid programs to ensure they are able to meet patient and resident needs during emergency situations. The regulation went into effect on Nov. 16, 2016, and Medicare and Medicaid participating providers and suppliers must comply with the new regulations by Nov. 16, 2017.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/CMS-EMERGENCY-PREPAREDNESS-RULE-506497/AUGUST-2017-ES-TRAININGREGISTRY
This risk management training examines the significant changes that have taken place in the global and business threat landscape. It points out the inherent weaknesses that prevail in current contingency plans and lists action steps to take to upgrade them.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/CONTINGENCY-BUSINESS-CONTINUITY-PLAN-503539/AUGUST-2017-ES-TRAININGREGISTRY
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.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/BAD-STANDARD-OPERATING-PROCEDURES-SOPs-506264/AUGUST-2017-ES-TRAININGREGISTRY
There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations.
This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11.
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An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps.
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