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Joseph Wilcox

Traininng.com is a provider of world class online professional training in the areas of regulatory compliance and healthcare. Traininng.com is the preferred learning destination for professionals from around the world. Traininng.com is a knowledge platform that seeks to help professionals learn, educate and succeed in their areas of work, and to bridge gaps.

Managing Generations, Motivate Different Generations, Millennials at Work- 2020. Overview Being able to manage and motivate employees that have more experience than you means being able to put aside your ego and focus on understanding different views of those generations you manage.

Managing Generations, Motivate Different Generations, Millennials at Work- 2020

It is up to you to take the lead and create the climate in which older workers will remain engaged and productive. This webinar focuses on providing you the topics that you need to learn in order to understand how to manage different generations, especially millennial employees. Why you should Attend In today's five-generation American workforce, the younger generations are finding themselves in management positions, managing workers that may be significantly older and possess more work experience. Areas Covered in the Session.

Managing Generations: How to Manage, Engage and Motivate Different Generations, Especially Millennials at Work

The New EU Medical Device Regulation. Overview Regulation proposals of the European Commission.

The New EU Medical Device Regulation

Background. 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. This webinar will look at what to expect when the new regulation is implemented.

HPLC Analytical Method Development and Validation. Overview Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

HPLC Analytical Method Development and Validation

The focus of most validation work is on the methodology, the standard operating procedure (SOP). Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs. Overview Bank Secrecy Act requires financial institutions to assist government agencies to detect and prevent money laundering.

Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs

In May 2013 FinCEN published issue #23 of The SAR Activity Review Trends Tips & Issues. Table 2 documents the most frequent activities defined in Category S - Other. Tax Fraud or Evasion makes up 22% of those cases. Performing your Annual HIPAA Security Risk Assessment. Overview In September of 2017, OCR shared preliminary results of their Phase 2, nation-wide, HIPAA Audits.

Performing your Annual HIPAA Security Risk Assessment

As it relates to HIPAA Security Risk Analysis and Management the results were pretty shocking. OCR reported that 83% of those they audited had a score of "inadequate" or "failure" on their performance of an information security risk analysis while 94% had a score of "inadequate" or "failure" on their efforts of establishing or maintaining an information security risk management plan.

A couple months ago the OCR announced their $3.5 million settlement with Fresenius Medical Care North America (FMCNA). The main reason cited by the OCR was that Fresenius "failed to heed HIPAA’s risk analysis and risk management rules. " He said, "The number of breaches, involving a variety of locations and vulnerabilities, highlights why there is no substitute for an enterprise-wide risk analysis for a covered entity. Why should you Attend HIPAA enforcement is on the rise. Areas Covered in the Session C.J. Packaging and Labelling in the Pharmaceutical Supply Chain.

Overview Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision.

Packaging and Labelling in the Pharmaceutical Supply Chain

Leadership Simulation: Designing Your Own Leadership. Overview As you grow leadership in others, you will have both managers and leaders attend your sessions.

Leadership Simulation: Designing Your Own Leadership

Although rare, you may meet learners who know how to jump between both roles effectively. Both roles of manager and leader are critical to your organization. Both roles are difficult to staff and when staffed with good people, magic happens. Managers are usually grown from within - coming up from a functional job to lead others in that functional job. But the truth is, it is very difficult for a manager to leave the day-to-day operations that have created success to jump into the unknown of leadership. Learn how to build a workshop designed to help an individual see where they want to be.

One small warning - growing management and leadership is not for the faint of heart. Growing management or leadership is not a project, it's a process. Why should you Attend Leadership competencies cannot be developed by sitting through lectures. Areas Covered in the Session. Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks. Overview This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including: How to link risk with the confidence statements associated with the sampling plansIdentify a variety of sampling plans, that all make the desired confidence statementsSelect from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validationHow to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates Why should you Attend In the medical device industry acceptance sampling plans are required for Validation/Verification/Effectiveness studies that must: Be based on a written procedureAligns the plans to riskProvides a valid statistical rationale Areas Covered in the Session Who Will Benefit Speaker Profile Dr.

Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks