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- Time:
- 5:00pm-6:30pm
- Description:
- DESCRIPTION
• HHS has issued new detailed guidance on the appropriate provision of access to individuals' PHI in response to widespread complaints of noncompliance by the public and significant lapses in compliance discovered in prior HIPAA audit and enforcement activity.
• Changes modifying the HIPAA Privacy and Security Regulations have gone into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009, as implemented in the HIPAA Omnibus Update rule published January 25, 2013, and the recent changes to the Clinical Laboratory Improvement Amendments. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules. And if you are required to have a HIPAA Notice of Privacy Practices, that must properly reflect the new rights that patients have.
• Medical laboratories are now required to provide individual access to test records, and will need to have processes to authenticate those who request information and the means to ensure that the correct results are provided to authenticated individuals.
• HHS has recently issued guidance on issues relating to access of mental health records, clarifying what information may be provided or not, depending on the information and other circumstances.
• The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be changed and how. We will show what policies and evidence you may need to produce if you are audited by the HHS Office of Civil Rights, which has already indicated that compliance with the rules on patient access of records is a significant problem that is likely to be a focus of the new HIPAA Audits in 2015.
• Not only are the compliance rules changed, but the enforcement rules have changed, with a new four-tier violation schedule with increased minimum and maximum fines, and mandatory fines for willful neglect of compliance that start at $10,000 even if the problem is corrected within 30 days of discovery. Violations that are not promptly corrected carry mandatory minimum fines starting at $50,000 and can reach $1.5 million for any particular violation. And any reports of willful neglect are required to be investigated under the law. Even violations for a reasonable cause or with reasonable diligence taken are subject to penalty. We will discuss what is necessary to avoid penalties and make sound compliance decisions.
• This Webinar will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be in compliance with the new regulations. It will provide a comprehensive look at the changes in the rules on access and prepare attendees for the process of incorporating the changes into how they do business in their facilities.
Why should you attend :
• Patient rights under HIPAA include several new rights of access, and new guidance has been issued on access, in addition to recent guidance on access of mental health records and the records of minors. These changes must be respected by entities subject to the HIPAA rules through modifications to policies and notices, and training of staff to reflect the new requirements.
• The HIPAA Omnibus Update rules contain numerous changes to HIPAA Privacy, Security, and Breach Notification rules, including some having to do with patient access of records that will need to be reflected in every health care-related organization’s policies and procedures. Several policies and procedures will need to be reviewed and updated to meet the new requirements.
• Patients also now have new rights under HIPAA and the Clinical Laboratory Improvement Amendments (CLIA) to directly access test results from the laboratories creating the data. Many labs that did not deal directly with patients before will now have to create patient-facing operations, and how they communicate sensitive results to patients will need to be considered.
• HIPAA now provides for individual rights to receive electronic copies of records held electronically, new rights to access laboratory test results, and new explanations from HHS about how to treat access to mental health information, including giving due consideration to patient requests and safety issues of the patient and others.
• The HIPAA Audits of 2012 revealed that providing the proper paitent access to information is asignificant compliance problem, and the new HIPAA Audit program by HHS is expected to include reviews of patient access polices and practices.
• All HIPAA-covered providers need to review their HIPAA compliance, policies, and procedures to see if they are prepared to meet the changes in the rules. Compliance is required and violations for willful neglect of the rules begin at $10,000. The enforcement rules have changed, with a new four-tier violation schedule with increased minimum and maximum fines.
Areas Covered in the Session:
• Learn about the new HHS guidance on appropriate provision of access of PHI by individuals.
• Learn about the new access rights under HIPAA and CLIA regulations.
• Learn about the guidance from HHS regarding access of mental health information and minors' information.
• Find out what the regulations call for and what processes you must have in place for the proper approval and denial of access as apporpriate.
• Learn about the required process for the review of certain denials of access.
• Learn how e-mail and texting should be handled, what can go wrong, and what can result when it does.
• Find out about HIPAA requirements for access and patient preferences, as well as the requirements to protect PHI.
• Learn about the training and education that must take place to ensure your staff handles access requests properly.
• Learn about how the HIPAA audit and enforcement activities are now being increased and what you need to do to survive a HIPAA audit.
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=hhs-guidance
Note: Use coupon code < T9AIO8AY> and get 15% off on registration.
- 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:
- 3:30pm-4:45pm
- Description:
- Many retailers leave money on the table as they are not able track and control their inventory efficiently. This can lead to huge wastage of resources and slow business growth.
However, with Orderhive, retailers can automate inventory process and leverage their resources to full potential.
During the webinar, you'll the learn:
- Problems of multichannel selling that every retailer needs to solve
- Using a centralized inventory software as a solution
- How Orderhive's centralized interface can help
- How to automate and manage processes via Orderhive
Who should attend?
Online retailers, brick-and-mortar retailers, wholesalers, traders, manufacturers, distributors. Sellers who are using multiple channels (Amazon, eBay, Etsy, Shopify, Bigcommerce) to sell should attend the webinar to understand how they can manage and centralize their inventory.
About the hosts
The webinar will be hosted by Jayneel Patel, CEO of Orderhive and Megha Vishnoi, Marketing Manager of Orderhive.
Register now to save your seat!
WHEN
Wednesday, March 16, 2016 from 11:30 AM to 12:30 PM (EDT)
- Time:
- 5:00pm-6:00pm
- Description:
- DESCRIPTION
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.
FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.
FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained
Why should you attend :
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means.
Areas Covered in the Session:
Company certification
Records covered
Audit trails
Open /closed system access rules
Electronic signatures
Training requirements
Who will benefit: (Titles)
Engineering personnel
QA
IT
Management
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:
- 5:00pm-6:30pm
- Description:
- DESCRIPTION
Topic Background:
Many Years Ago Schering Plough underwent the first Consent Decree.
Since, then many years elapsed and the term Consent Decree was foreign to many employees and employers and to Industry overall.
Over the last Seven Years there has been a Huge Onset of Regulatory Enforcement and Consent Decree Action!!!
Description :
This webinar will focus on current Food and Drug Administration (FDA) Regulatory Guidance ad well as current Regulatory Trends in regards to specifically Consent Decree.
In the recent past there has been an explosion of Regulatory enforcement specifically involving Consent Decree.
This webinar will focus on key Quality Systems that are being highlighted in many of the Consent Decree’s, such as Computer Systems Validation (focusing on 21CFR Part 11, Electronic Records and Signatures (ERES), Equipment Qualification, Change Control Systems, Proper Laboratory Investigations, Corrective Action/Preventative Actions (CAPA), Root Cause Analysis (RCA), etc.
Overall, this Webinar/Course will provide the attendees with the Ultimate set of Tools in order to help their firms during a Regulatory Inspection as well as helping to avoid falling under Consent Decree Status.
Why you should attend the training:
This webinar is directed towards executive management. Quality Assurance, Quality Control and Regulatory and Compliance staff who are involved in Consent Decree projects.
Objectives of the Topic :
Learning about the History of Consent Decree
Discussing the Schering Plough historical Consent Decree Case
Key Quality System Examples Highlighted in Many Consent Decrees
Computer Systems Validation Focus
A) 21CFR Part 1
B) ERES (Electronic Records and Electronic Signatures)
Current Domestic Food and Drug Administration Regulatory Trends
Overall, Current Global Regulatory Enforcement Activity
Summary of Lessons Learned during Regulatory Enforcement/Consent Decree
Areas covered during the Session:
Consent Decree Definitions
Current Food and Drug Administration Trends
Current Regulatory Enforcement Activity
History of Consent Decree
Recent Trends In Consent Decree
Consent Decree Focus on specific Quality Systems
Regulatory Trends Focusing on Computer Systems Validation
21CFR Part 11
ERES (Electronic Records and Electronic Signatures
Current Domestic and International Regulatory Trends
The following Disciplines will benefit directly from this Webinar :
Quality Assurance
Quality Control
Regulatory Compliance
Validation
Information Technology (IT)
Laboratory Information Management Systems (LIMS)
Research and Development(R&D)
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=consent-decree
Note: Use coupon code < T9AIO8AY> and get 15% off on registration.
- Time:
- 5:00pm-6:00pm
- Description:
- Marriage & Family Therapist and author Patrick Thyne has counseled countless grieving people in the course of his career. In this webinar, Patrick offers practical, actionable advice to help you be the strong support your good friend needs after experiencing a loss.
- 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
This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.
Why you should attend:
Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain and effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient CAPA system leads to wasted time and resources.
Areas covered in the Webinar:
This 90-minute webinar will focus on how to improve your CAPA process to optimize efficiency and effectiveness. Topics to be covered include:
FDA and NB expectations for CAPA
Lessons Learned from 483s and warning letters
Common problems CAPA
How to structure your CAPA process
How to use IT tools to monitor and maintain your CAPAs
Metrics to ensure your CAPAs are timely and effective
A toolkit for CAPA
Best Practices
Who will benefit:
Quality Systems Specialists
Document Control Specialists
Quality and Compliance Specialists
Internal Auditors and Managers
Training Specialists
CAPA Specialists
Supplier Quality Engineers and Auditors
Quality/Compliance managers or directors for Medical Device companies
General Managers wanting to learn how to understand Quality System requirements
Webinar includes:
Q/A Session with the Expert to ask your question
A copy of the PowerPoint slides
90 Minutes Live Presentation
Attendance of Certificate
For Registration : http://c2gowebinars.com/product/?topic=capa-medical
Note: Use coupon code < T9AIO8AY> and get 15% off on registration.
- Time:
- 7:00pm-8:30pm
- Description:
- Do you have BIG plans for your business this year?
If it’s time to finally break through that elusive 6-figure barrier, join us for the
$100k Breakthrough Blueprint
If you crave some straightforward strategies to help you to have a record-breaking year then join us on Thursday, March 17th at Noon PT, (3pm ET; 7pm GMT) for a no-cost online training. I'll also be answering questions LIVE, so come along with your marketing questions & challenges.
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3 key questions to ask yourself before you spend another dime [or another minute] on marketing
What you MUST start doing immediately if 2016 is going to be your 6-figure breakthrough year.
5 shifts to make that will create massive growth in your revenues & cash flow. [Some of these will surprise you!]
A misconception that keeps you struggling and working way too hard for not enough money.
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