WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Hazard Analysis and Risk Management under ISO 14971:2007/2012

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701693

In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.

Recording Available

* Per Attendee $299

 

Understanding FDA Design Verification and Validation Requirements for Medical Devices

webinar-speaker   Meena Chettiar

webinar-time   75 Min

Product Id: 705331

This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.

Recording Available

* Per Attendee $299

 

Internal Audit For Medical Device Companies - How To Make Your Audit Program More Effective

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706445

Internal audit should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance and quality risks. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.

Recording Available

 

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 703313

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

Recording Available

* Per Attendee $349

 

The Corona Virus and Telecommuting! How are Employers Handling the New Normal for a Remote Workforce?

webinar-speaker   Margie Pacheco Faulk

webinar-time   90 Min

Product Id: 706439

The coronavirus, also known as COVID-19, is spreading rapidly across the globe and throughout the United States. Accordingly, employers should keep track of rapidly emerging developments and consider taking the 10 steps discussed in the training order to maintain a safe workplace and to reassure their employees that management is appropriately monitoring and responding to the situation. Having a carefully coordinated and well-thought-out approach to the coronavirus should help mitigate risks for employers while reducing many employee concerns.

Recording Available

 

Heroic HR - Moving from Data Management to Information Craftsmanship with the help of HR Technology

webinar-speaker   Marc Miller

webinar-time   60 Min

Product Id: 706422

Based on Marc Miller’s popular book HeroicHR – this topic explores the needed and important role of the HR function within any size organization. With the emergence of AI, and the now majority of the US workforce being Millennials, the need for HR to take a visible leadership role in implementing OnBoarding and Employee Engagement and Talent Management initiatives is critical for the functions’ remaining to be relevant. The use of HR Technology is a critical component of that relevance.

Recording Available

 

Data Integrity - It's Not New and So Much More than Just Computers

webinar-speaker   David Husman

webinar-time   60 Min

Product Id: 706410

This webinar will discuss the recent attention regulators have placed on data integrity and show how the requirements are not new. The sources of data issues go far beyond the laboratory and are not just found in computer/electronic systems.

Recording Available

 

Pharmaceutical Pricing - a Global Perspective - US, EU and ASEAN

webinar-speaker   Peter Wittner

webinar-time   60 Min

Product Id: 706400

Prices for some products can vary from around $1,000 per pack in the US to one third of that for the certain product in South East Asia. In EU markets, prices are in between these two extremes and the same product can sell for anything between one-half and two thirds of the US price. The webinar sets out to examine these difference, explain how the price variations have arisen and aims to provide participants with some insights into ways of coping with them when moving into new markets.

Recording Available

 

Designing Medical Devices for Safety with High Return on Investment

webinar-speaker   Dev Raheja

webinar-time   60 Min

Product Id: 706271

This webinar will cover the new paradigms for designing safe products. It will discuss how to plan for Zero Defects at little or no cost resulting in high return on investment. It will cover real industry examples from the instructor’s experience.

Recording Available

 

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

webinar-speaker   Jose Mora

webinar-time   90 Min

Product Id: 705692

This webinar will help you better understand test method validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.

Recording Available

* Per Attendee $229

 

Managing Remote Employees

webinar-speaker   Audrey Halpern

webinar-time   60 Min

Product Id: 706437

Working remotely is becoming more of a norm in the tech industry. Various studies have shown that it is more difficult to get virtual teams to bond, harder for informal leaders to emerge, tougher to create genuine dialogue, and easier for misunderstandings to escalate. Leaders must deal with an array of cultural issues that can include differences in business protocol, decision-making, dealing with authority, the concept of time, negotiation styles, and the emotional reactions allowed – or expected – in a business environment. In this webinar you will learn how to communicate, establish trust and build strong working relationships.

Recording Available

 

Staying / Becoming Compliant by Correctly Completing or Correcting Form I-9

webinar-speaker   Norman Baker

webinar-time   90 Min

Product Id: 706436

This webinar will walk you through completing Form I-9 correctly and how to appropriately correct incorrect prior Form I-9’s, ideally in a pro-active manner before ICE audits your organization.

Recording Available

 

How To Implement An Effective Human Error Reduction Program

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706156

Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site.

Recording Available

* Per Attendee $299

 

How to Manage and Minimize COVID 19 in the Workplace

webinar-speaker   Tonia Morris

webinar-time   60 Min

Product Id: 706441

The Coronavirus known as (COVID 19) has totally disrupted the workplace, where anxiety and the way business is done has changed forever. For many organizations having a plan is the BEST course of action, and with the changing national condition, employers are feeling the growing concerns. As this pandemic continues to unfold each day, there are steps employers can take to manage and minimize chaos in the work environment so employees can continue to be productive and safe at work. This session provides attendees with current helpful tips to address the rapid changing circumstances and concerns in managing the Coronavirus (COVID 19) threat in the workplace.

Recording Available

* Per Attendee $229

 

7 Attributes of High Octane Leaders

webinar-speaker   Biagio Sciacca

webinar-time   60 Min

Product Id: 706427

This webinar is designed to assist the participants in the rapid assimilation of new ideas that can become part of their managerial and leadership repertoire. The notion of "Personal Kaizen" will be introduced in terms of developing, embracing and incorporating new ideas that will bring about changes in behavior. New Idea assimilation will be introduced in terms of a concept called "The Slight Edge".

Recording Available

* Per Attendee $229

 

Leadership in a VUCA World

webinar-speaker   Annie Abrams

webinar-time   60 Min

Product Id: 706440

Volatility, Uncertainty, Complexity, and Ambiguity, otherwise known as VUCA aren’t going away — and confusion will remain part of the mix. The next 10 years will be exceptionally volatile, with many make-or-break decisions to be made. Leaders must do more than just respond to the whirl of events, though respond they must. They must be positive change agents in the midst of chaos, creating the future.

Recording Available

 

EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706170

Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.

Recording Available

* Per Attendee $299

 

Yes, It's Possible! Tools for Concurrently Enhancing Compliance, Knowledge Transfer and Process Efficiency

webinar-speaker   Mike Kent

webinar-time   60 Min

Product Id: 706347

This webinar will illustrate a set of unique tools that simultaneously address challenges of improving awareness, accessibility and compliance with process-related information. Learn how to construct solutions that people across your organization can use to better understand how processes work and how their role fits in, all in ways that complement your existing procedures and document structure. You may also find these tools useful when performing investigations, identifying and mitigating potential risks, and describing a process to a regulatory inspector.

Recording Available

 

Brazilian Regulatory System for FDA Regulated Industry: Pack of 10 Training Courses

webinar-speaker   Robert J Russell,Eliana Silva de Moraes,Juan M Campos

webinar-time   16 Hrs

Product Id: 706488

Recording Available

* Per Attendee $1799

 

Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability

webinar-speaker   Dr. Susan Strauss

webinar-time   75 Min

Product Id: 704699

This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart strategic community outreach efforts to the LGBT population.

Recording Available

* Per Attendee $219

 

 

 

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