- Time:
- 5:00pm-6:30pm
- Description:
- DESCRIPTION
The FDA’s Quality System Regulation (QSR) prescribes a medical device manufacturer’s Quality Management System (QMS). The webinar describes the five components of Management Responsibility by reviewing the regulations, inspection methods, and Warning Letters.
The webinar examines the requirements for management responsibility using FDA based information. We examine the regulation in 21 CFR §820.20, discuss its constituent parts, and explain the many defined terms.
The webinar draws on many sources to provide the understanding you need for an effective implementation. One rich source is the preamble in which FDA-CDRH responded to suggestions and comments about the draft regulation. The Quality System Inspection Technique (QSIT) guides Investigators during an inspection. QSIT includes flow charts and narrative that the webinar incorporates. Warning Letters represent problems that FDA Investigators uncovered during inspections and provide an opportunity for you to avoid them.
Areas covered in the webinar:
The five components of Management Responsibility
The special terms that FDA uses
The approach an FDA Investigator takes using QSIT
Warning Letters to illustrate some of the issues encountered
Tips for successful implementation
Who will benefit:
Device company executives
Device company managers
Management Representatives
Quality Assurance Managers
Regulatory Affairs Managers
Why you should attend:
This is a key area in an effective management system for quality. In this webinar you will learn the requirements, understand how to implement them, and learn what FDA Investigators expect when they check your compliance.
Webinar includes :
A bonus checklist to help guide effective implementation
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
For Registration : http://c2gowebinars.com/product/?topic=management-responsibility-dan-o-leary
Note: Use coupon code <T9AIO8AY > and get 15% off on registration.
- Time:
- 5:00pm-6:30pm
- Description:
- DESCRIPTION
The FDA’s Quality System Regulation (QSR) prescribes a medical device manufacturer’s Quality Management System (QMS). The webinar describes the five components of Management Responsibility by reviewing the regulations, inspection methods, and Warning Letters.
The webinar examines the requirements for management responsibility using FDA based information. We examine the regulation in 21 CFR §820.20, discuss its constituent parts, and explain the many defined terms.
The webinar draws on many sources to provide the understanding you need for an effective implementation. One rich source is the preamble in which FDA-CDRH responded to suggestions and comments about the draft regulation. The Quality System Inspection Technique (QSIT) guides Investigators during an inspection. QSIT includes flow charts and narrative that the webinar incorporates. Warning Letters represent problems that FDA Investigators uncovered during inspections and provide an opportunity for you to avoid them.
Areas covered in the webinar:
The five components of Management Responsibility
The special terms that FDA uses
The approach an FDA Investigator takes using QSIT
Warning Letters to illustrate some of the issues encountered
Tips for successful implementation
Who will benefit:
Device company executives
Device company managers
Management Representatives
Quality Assurance Managers
Regulatory Affairs Managers
Why you should attend:
This is a key area in an effective management system for quality. In this webinar you will learn the requirements, understand how to implement them, and learn what FDA Investigators expect when they check your compliance.
Webinar includes :
A bonus checklist to help guide effective implementation
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
For Registration :http://c2gowebinars.com/product/?topic=management-responsibility-dan-o-leary
Note: Use coupon code <T9AIO8AY > and get 15% off on registration.
- Description:
- Industry: Biotechnology , FDA Regulated Industries , Medical Device , Pharmaceutical
Speaker: Carolyn Troiano
DESCRIPTION
The Webinar will discuss the importance of performing a thorough, yet cost-effective computer system validation effort. Regulatory agencies fully expect companies to identify each risk up front, in order to demonstrate they have all been assessed for the likelihood of occurrence and severity of impact.
Risk management of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing your computer system validation effort, regulatory agencies will expect you to have a risk management plan in place that specifies how you will mitigate each risk associated with a computer system, and how you continue to monitor it. They will also be looking for metrics that indicate how the system rates in terms of risk at implementation time (baseline), and how ongoing monitoring and action further mitigate or eliminate it.
Along with risk assessment, categorizing your system according to GAMP 5 guidelines will enable you to develop the most cost effective approach to computer system validation without sacrificing compliance.
We will share some cases from industry that demonstrate how developing this type of strategic approach r reduces the total cost of validation while ensuring maximum compliance.
Why should you attend :
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. With government agencies downsizing staff, there are fewer agents to visit companies and conduct on site audits, and those conducted must be completed in a shorter period of time.
To compensate for this, it is vital that you know the risks associated with each of your systems and have a solid plan for mitigating these and monitoring them over time. This will expedite the process and reduce the overall time and cost of an audit. It will also keep the audit and line of questioning within scope, which reduces unnecessary work for both parties.
Assessing the risk and categorizing you system according to GAMP 5 guidelines will enable you to develop a strategic approach to computer system validation that will meet FDA compliance.
As cost is a significant factor in any system implementation and validation effort, you will learn about ways to lower those costs without sacrificing compliance.
Improving the quality of documentation in preparation of an audit will result in cost savings and free resources up to work on more pressing company interests. Preparedness is also a factor in building a more positive relationship with the auditing agency, generating greater trust and cooperation.
As mergers and acquisitions continue within the FDA-regulated industries, it is also vital to develop a strategy based on how much risk your operation is willing to tolerate. Merging organizations that do not share a common philosophy will result in confusion and may mean that employees will leave, rather than change their ethical beliefs.
Areas Covered in the Session:
- Provide an overview of FDA oversight and compliance objectives
- Provide an overview of Computer System Validation (CSV) and the System Development Life Cycle (SDLC) approach used as a framework for conducting CSV activities
- Describe basic risk assessment and management concepts, explaining the various components and metrics involved
- Explain GAMP 5 system classification and how to apply it when developing a CSV approach
- Develop the ability to apply the SDLC when validating computer systems in your organization
- Understand the best practices for maintaining a computer system in a validated state
- Discuss the best practices necessary to ensure all systems are validated appropriately
- Provide an overview and details of the process for validating a computer system such that cost is minimized while compliance is maximized
CSV activities
- Apply the strategic approach to CSV to one or more actual computer systems that are typically used in industry (laboratory, clinical, manufacturing)
- Provide an example of the output generated from the process of developing a CSV strategic approach
- Discuss the presentation of the organization’s CSV strategy and rationale to the regulatory agency
CSV activities
Provide an overview of trends in FDA compliance related to CSV strategic planning, focusing on recent findings and how to avoid these
- Q&A
Who will benefit: (Titles)
Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers
This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.
Webinar includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of attendance
- 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:
- 2:00pm-3:00pm
- Description:
- Join the next webinar by Toradex to learn about the different versions of SDK, Operating Systems supported by Toradex, and the development tools and libraries that can be used to build Internet of Things solutions using Toradex’s devices as the hardware platform. You will also see a fascinating demo showcasing the real-world implementation of this technology.. For more information on the Webinar and registration details check out this link: https://www.toradex.com/webinars/getting-started-with-azure-iot-on-devices
Date and Time: Wednesday, April 20, 2016 10:00 - 11:00 (CEST) & 10:00 - 11:00 (PST)
Speakers:
• Valter Minute, Embedded Software Engineer, Toradex
• Héctor García Tellado, Program Manager, Microsoft Azure IoT
- Time:
- 6:00pm-7:00pm
- Description:
- Free Webinar!
Getting an effective benefits strategy in place for the future starts now! Join Marybeth Gray of Trion for an information-filled webinar to kick start your strategy session. She will discuss the current state of the market and key challenges facing employers offering employee medical coverage. Find out how other employers are effectively involving the “C” suite in benefits strategy development. Leave this webinar with a clear understanding of the top proven strategies to lower costs of both medical and ‪#‎pharmacy‬ benefits
Participants in the live ‪#‎webinar‬ will earn (1) ‪#‎HRCI‬ general re-certification credit or (1) ‪#‎SHRM‬ re-certification credit.
ow.ly/100HQQ
‪#‎HR‬ ‪#‎Finance‬ ‪#‎benefits‬ ‪#‎healthcare‬
- Time:
- 2:00pm-3:00pm
- Description:
- Hathway surveyed 500 mobile consumers to find out what they want most from a brand’s mobile app. Join our webinar on April 21st to hear the fascinating results and how it impacts your business.
In the webinar "Branded Apps Impact Sales & Consumer Loyalty,” Hathway’s CSMO Kevin Rice will share what consumers said about their branded apps, what's missing from those apps, the impact a better-built app could have on their buying behaviors, and what your brand can do to meet consumers' demands.
Register today: http://wearehathway.com/blog/branded-apps-webinar/
Webinar: Branded Apps Impact Sales & Consumer Loyalty
4/21 at 10am PT
- 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:
- 5:00pm-6:30pm
- Description:
- DESCRIPTION
The topic of HIPAA compliance will be covered in a format of “10 Days to HIPAA Compliance” wherein focusing the work to be done according to 10 topic areas helps ensure the essential issues are considered. While compliance may take more than 10 days of effort depending on the organization, the 10 topic areas focus the work of the HIPAA Privacy or Security Officer so that progress in compliance can be made and documented.
Day One: Research of Your Operations – How do you use PHI and what policies and procedures do you have for Privacy, Security, and Breach Notification? Understand your operations and information flows, and the ways you use or disclose PHI.
Day Two: Limitations on Uses and Disclosures – Establish the proper limitations according to the Privacy Rule, including requirements for Business Associates, handling authorizations, and required processes for uses and disclosures of PHI under HIPAA.
Day Three: Patient Rights under HIPAA – Make sure the processes are defined and in place for providing opportunities to access, amend, and restrict uses of PHI, to ask for an accounting of disclosures of PHI, to request alternative means or methods of communication, and to receive a Notice of Privacy Practices.
Day Four: HIPAA Risk Analysis – Look at how you handle information, identify the risk issues, and decide their priority for mitigation.
Day Five: HIPAA Security Safeguards – Decide what safeguards you will use to address the various Security issues and start implementing physical, technical, and administrative safeguards.
Day Six: HIPAA Security and Breach Notification Policies and Procedures – Adopt a thorough process for managing, evaluating, and acting on any incidents involving PHI and breaches of PHI.
Day Seven: Documentation of Policies and Procedures – All the things you’ve been doing need to be properly documented so you can show compliance. Just creating documentation alone is easily a day’s work.
Day Eight: Training in Policies and Procedures Related to HIPAA – Once you have your HIPAA policies and procedures ready, you can begin training staff on your own policies and procedures relating to privacy, security, and breach notification.
Day Nine: Verification and Audits of Compliance – Implementation of HIPAA Privacy, Security, and Breach Notification compliance should be regularly evaluated to ensure that policies are being followed and systems are secured.
Day Ten: Long Term Compliance Planning and Risk Management – To establish and maintain compliance, it is essential to implement one-time actions, to schedule compliance activities that should take place regularly, and to identify that which can trigger the need for security maintenance and risk management activities.
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures, but also that you ensure you have the right policies, procedures, and documentation, and have performed the appropriate analysis of the risks to the confidentiality, integrity, and availability of electronic Protected Health Information. Doing so is essential to protect your PHI from exposure through accidental acts, such as a loss of a device holding data, or intentional acts, including the recent increases in attacks of health information by hackers.
The session will include a discussion of the various HIPAA-defined safeguards that must be considered, and the kinds of policies and procedures that must me implemented, in order to properly comply with the rules and protect the privacy and security of PHI from accidental or intentional exposure, misuse, or improper disclosure.
Why should you attend :
While all HIPAA Covered Entities and Business Associate are subject to the HIPAA Privacy, Security, and Breach Notification Rules, not all entities have done all that’s necessary, and many have not reviewed their compliance recently. If you haven’t taken care to be in compliance with the HIPAA rules, and there is a privacy or security incident affecting Protected Health Information, or you are selected for a random audit, or someone make a complaint alleging HIPAA violations, you can face serious penalties.
It is essential today to regularly review your HIPAA compliance to make sure you are staying up with rule changes and are prepared to answer questions from inspectors or investigators. This 90-minute session will step through the basics of HIPAA compliance and identify current compliance issues that should be addressed to ensure a clean report in any reviews.
Areas Covered in the Session:
Research of Your Operations
Limitations on Uses and Disclosures
Patient Rights under HIPAA
HIPAA Risk Analysis
HIPAA Security Safeguards
HIPAA Security and Breach Notification Policies and Procedures
Documentation of Policies and Procedures
Training in Policies and Procedures Related to HIPAA
Verification and Audits of Compliance
Long Term Compliance Planning and Risk Management
Who will benefit: (Titles)
Compliance director
CEO
CFO
Privacy Officer
Security Officer
Information Systems Manager
HIPAA Officer
Chief Information Officer
Health Information Manager
Healthcare Counsel/lawyer
Office Manager
Contracts Manager
Webinar includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of attendance
For Registration : http://c2gowebinars.com/product/?topic=hipaa-compliance-project
Note: Use coupon code < T9AIO8AY> and get 15% off on registration.
- Time:
- 7:00pm-8:00pm
- Description:
- In this session we will cover the following topics:
• The importance of risk treatment in an effective risk management system
• Determining whether to treat or not to treat risks(cost/benefit analysis and the ALARP principle)
• Options for treating risks
• Conclusions
This session will be presented by PECB trainer Jacob McLean, Principal Consultant and Managing Director of Kaizen Training & Management Consultants Limited