Education Technology

Join this webinar to be better prepared to comply with new regulation, as well as understand the terms and definitions used in GDPR relevant to clinical trials. 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/EU-GDPR-Deadline-is-Just-around-the-Corner-Understanding-Compliance-for-Clinical-Trials-for-Life-Sciences-Companies-503375/MAY-2018-ES-TRAININGREGISTRY

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

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 software’s are now available to professionals. However, these software’s 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?

What do the regulations say? Navigate the FDA drug and device approval system Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings Navigate the FDA review process Identify the required regulations and guidance documents for drug and biologic submissions Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions Formulate a working knowledge of regulatory submissions, publishing, and style guides

One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls.

GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.

Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis - Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit.

Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis, also you will learn how to Analyze and document the root cause of the problem. Why should you Attend: The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop failure investigation / root cause analysis as an integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution.

Overview: Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. Why should you Attend: The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market.

Overview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing activities in GXP areas to remain compliant. Areas Covered in the Session: Discover Tools and Processes to Manage CROs/other Vendors Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations

The process validation guidance document defines the need for this stage: "After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change." Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process.

This seminar will be of benefit to anyone working in a GMP regulated environment on global or domestic scale within the pharmaceutical and medical device industry. This includes quality, validation, engineering, manufacturing, and management personnel from sponsors and contract manufacturers (CMO) alike. This is anyone who wants to improve their ability to solve recurring problems should attend this training. Additionally, those who are actively involved in performing, overseeing, auditing, or managing investigations will find this course extremely beneficial.

The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have far reaching effects on Quality Management Systems so it is critical to understand what has changed with in ISO 13485: 2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.

The concept of industrial compliance with applicable laws and regulations deals with obeying the statutory requirements to which the entity is subject. Compliance infers acceptance. Societal expected behavior acceptance requires value(s) conformity to established norms.

This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.

What is MDSAP and where is it going? Will it eventually touch my business anywhere in the world? MDSAP is creating a playing field among regulatory bodies around the world. That playing field consists of the 6 critical regulatory bodies that are participating in the development of future considerations for an equivalent and reciprocal set of conscript elements of compliance to GMP conditions of operation. 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/Medical-Device-Single-Audit-Program-MDSAP-All-You-Need-To-Know-509189/MARCH-2018-ES-TRAININGREGISTRY

Overview: Managers are usually promoted to their role because of their technical skills and not their people skills. In fact, studies have shown almost a decade gap between when people get promoted and when people begin to seek out leadership skills. If you can understand where your boss is in the process, you may be able to help them become the boss you want them to be.

Overview: This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee. Several successful examples across various business types will be shared. Attendees will walk away with a model that they can apply to their own organizations.

Overview: Failure Mode and Effects Analysis (FMEA) is a powerful tool for product quality. It has its roots in reliability but has expanded into other areas including process control. The primary purpose is to investigate failures and the way (the mode) they happen. This leads to an evaluation of the failure's effect on the product or process and measures to manage it.