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- Description:
- Industry: Trade
Speaker: Jason Teliszczak
DESCRIPTION
A detailed look at each section of the standard.
Real world examples of what to expect, and what to prepare and repeal within the audit guidelines.
What must a documentation system look and feel like to ensure compliance?
These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp.
Clean rooms 101, we can assist in what to do and what not to do. From the infrastructure, to the maintenance, PPE, etc. It is a holistic system that must be maintained at optimal standards at all times.
How is the quality within the organization? Materials must be accounted for and properly maintained. Only the highest quality materials should be utilized to create a unique and durable product.
Your suppliers must be chosen carefully. Ensure that each vendor is vetted and reviewed at least annually. The product you are making cannot be at or maintain any level of quality unless the supply chain is acceptable and consistent.
A true and complete internal audit is key to ongoing certification. The system must be looked at entirely each year, and by independent parties to validate that each section of the standard is being met, and is consistently documented to be functional. Who should audit which section, what type of documentation must be kept; this will be reviewed and explained.
Management plays a key role with any certification. Their support is needed to implement and maintain the system for certification. Their roles should be clear, and they must be involved in the annual review to ensure that the system overview is known and communicated to all. This way ongoing changes, both good and bad, are feed back into the system to keep it live and continually improving as a whole.
Areas Covered in the Session:
An overview of the standard and the different areas needed to create, maintain, and sustain a proper documentation system to ensure certification.
Know what to look for and where to prepare to enable one’s organization and personnel to assist in an audit for certification.
Clean rooms
Supplier demands
Quality from when materials are received, until after the devices leaves the facility.
Annual upkeep
Management representation and participation.
Who will benefit:
Quality Managers, EH&S Reps, Quality Control, QCQA, CEOs, Sales, buyers, vendors, etc.
Webinar includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of attendance
- Time:
- 3:00pm-4:00pm
- Description:
- Most are aware of the significant opportunities presented by the Iranian market as a whole, and most particularly the automotive market. However, the real story surrounding the re-entry into Iran is the challenges the world's largest MNCs face.
This webinar provides examples of challenges currently faced in the marketplace - from regulatory issues, restrictive import tariffs, combatting the currently dominant grey-channels, to the muddy competitive landscape full of domestic and international players.
Join us for a free webinar with Erika Welch, Solidiance's Business Development Director of Middle East, as she discusses on:
- Prevailing challenges faced by global automotive players entering the Iranian market
- Opportunities in Iran's lucrative automotive industry after the removal of sanctions
- Interesting case studies related to success stories and failures
- Actionable strategies to overcome the challenges
Contact us at webinar@solidiance.com
- Time:
- 8:00pm-8:40pm
- Description:
- Steps Your Business Can Take to Mitigate the Risks and Ensure a Smooth Transition to The Cloud
This webinar is for executives who are serious about cloud computing, but are unsure of how to securely and efficiently make the transition.
We've done the reseach for you.
When researching cloud options, it's important to understand the risks, bottlenecks, and productivity traps of moving to a cloud computing provider.
During this webinar, you'll learn:
1.The Signs It’s Time To Migrate To The Cloud
2.Steps To Managing Cloud Expectations
3.How to Identify & Mitigate the Cloud Risks
4.How to Ensure a Smooth Transition To The Cloud
(If you're a cloud computing beginner, you may want to start with our 'Cloud Computing 101' webinar)
- Time:
- 11:00pm-12:00am
- Description:
- Learn new skills to master the various challenges associated with living with a chronic medical condition. Learn how to take charge of your healthcare and self-care. Discover new ways to give your life meaning and purpose, and explore how to best adapt to changes and losses.
This webinar series provides the road map that will guide you in how to increase wellbeing despite health challenges. By engaging in the mindfulness-based practices presented in these webinars, which were developed out of new advances in psychology, you will learn that the power to be the master of your condition and your life is in your own hands.
Each chapter focuses on a tool to cultivate wellbeing and ends with helpful hints on medical self-efficacy.
This educational webinar series will inform you of evidence-based tools developed from recent advances in psychology. To increase mastery wellbeing, self-care & your ability to work collaboratively & proactively with yon partnership with your doctors.
- Time:
- 3:00pm-4:00pm
- Description:
- The monitoring process according to upcoming ICH E6 (R2) is now becoming systematic, prioritized and risk-based. This is defined by the (Food and Drug Administration) FDA and (European Medicines Agency) EMA guidelines concerning quality by design, risk management and risk-based monitoring (RBM ).
With the FDA and EMA Risk-Based Monitoring (RBM) guidances as well as the upcoming ICH E6 (R2) changes, are you ready for RBM? This webinar will help you assess whether your organization is ready for RBM as well as discuss steps to take to implement RBM. During this webinar you will:
Gain an understanding of RBM in the more general context of Quality Risk Management
Understand the various tools and concepts of RBM
Learn about the foundation for building a Risk Management framework
Understand the steps needed to implement RBM in a Risk Management framework
Date/ Time: May 25th @ 11am EST
Speaker:
Angie Maurer
RN, BSN, MBA, CCRA
Owner/Principal, Maurer Consulting, LLC
Click here to register : http://www.ddismart.com/registration-for-are-you-ready-for-rbm-process-and-technology-wise
- Time:
- 6:00pm-7:00pm
- Description:
- Business architecture is a strategic differentiator. However there are practical applications of tools and techniques that will support and link business strategy to the tactical outcomes. By applying models and standards the business analyst and the project managers benefit from the alignment, clarity and re-usability of the business architecture. The objectives of the webinar are to:
Explain why bother doing business architecture
Describe business architecture as a complementary and supporting methodology to analysis deliverables
Demonstrate some cool tools PMs and business analyst could use
Show you how to be a hero to your business, developers, testers and customer
Provide a description of value Participants will acquire a functional knowledge of business architecture. The adoption of business architecture tools and techniques will support the management of requirements & risk by establishing clearer scope.
- Time:
- 2:00pm-3:00pm
- Description:
- This teleseminar is designed for Moms whose child has left home. This is a time of great change! this Teleseminar will provide support and ideas about how you can use this unique transition to thrive in your personal growth.
- Time:
- 3:00pm-4:00pm
- Description:
- This webinar will explore terrorist financing and AML and BSA efforts. The Instructor will discuss and evaluate the new forms of terrorist financing and recent global events, and their Impact, that occurred as a result. Participants will learn the different options that financial institutions could consider when implementing methods to address terrorist financing. They will also explore how to maintain constant vigilance and combat potential new forms of terrorist financing.
Why Should You Attend:
Terrorist financing is an unfortunate reality for the financial environment. Although many laws, regulations, and rules have been implemented to try to deter such activity from occurring, it still remains a critical concern for financial institutions. Financial institutions continue to be proactive in there monitoring efforts for identifying transactions that may be potential terrorist financing.
Who Will Benefit:
Compliance Managers & Officers
Risk Managers and Officers
BSA Officers /Personnel
BSA/AML Executive Managers
Presidents / Vice Presidents
Fraud Managers / Personnel
Instructor Profile:
Dr Gina J. Lowdermilk, PhD (ABD), CAMS, CRMS is a highly experienced and educated BSA/AML and financial regulatory compliance professional with extensive experience in policy and procedure development and implementation, training, internal audit, monitoring, risk management, and reporting.
Note:
Use coupon code NB5SQH8N and get 10% off on registration.
- Description:
- Join Dr. Joe Jacobsen as he examines the question Big Data or Big Science?
Joe will discuss the facilities requirements, technical challenges and solutions for data-driven decision-making and planning imperatives, that facility personnel must understand and act upon.
Dr Jacobsen is currently Professor of Business at Concordia University in Milwaukee, WI. His latest book, Sustainable Business & Industry is being adopted across the country as a textbook for graduate and undergraduate business and industry coursework.