Falsifying Data in clinical trials. What to report?

Course Description:

Falsifying data in clinical trials creates problems for the investigator, the investigator’s institution, the research participant, and the advancement of scientific knowledge. Unfortunately, each year there are headlines stating that some researcher has falsified, fabricated or plagiarized all or part of the research data. Should this activity be reported? but by who and when?  Looking at several case examples we can learn what to look for and what to report.  We will also discuss the regulations governing the ethical conduct of human subject’s research.

Course Objective:

Research integrity charges in and of themselves can be devastating to the researcher and the institution.  Not all activity that is questionable involves a violation of research integrity so knowing who to ask or where to go for guidance can help avoid a compromising situation. Conversely, know the rules before and while the research is conducted creates a culture of compliance which helps avert problems.

Course Outline:

  • What is research integrity?
  • Definitions for falsification, fabrication and plagiarism
  • What types of problems are created?
  • What should be reported?
  • Where should those reports go?
  • Who monitors and governs research integrity?

Target Audience:

This webinar will provide valuable assistance to all personnel in:

  • Human Subjects Research
  • Clinical Research Coordinator positions
  • Investigator positions
  • Administration in charge of Clinical Research
  • Regulatory Compliance
Advertisements

Medical Device Design Control: Get your Best Products to Market

Course Description:

The Webinar will discuss strategies for efficiently meeting the Design Control requirements as described in 21 CFR §820.30 to get your best products to market.

Course Objective:

Design Control is a critical area in marketing medical devices.  Having appropriate and effective Design Control processes in place can help one reach the market more quickly, avoid certain regulatory pitfalls, and meet the needs of your customers.

 

Course Outline:

  • Describe the primary benefits of implementing and maintaining effective Design Controls.
  • Review the requirements of Design Control.
  • Introduce a methodology for evaluating existing Design Control processes.
  • Outline implementation of an effective Design Control process.
  • Elements of an effective Design Control process.
 

Target Audience:

QA managers or project managers, Regulatory managers or project managers, or Product Development managers or project managers.
 
Learning Objectives:
Upon completion of this session, attendees will understand key benefits to implementing and maintaining an effective Design Control process as well as the associated regulatory requirements.  Attendees will also gain a basis for evaluation of existing Design Control processes and implementation of improvements or new processes.

Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality

Course Description:

This medical foods regulatory compliance training will explain the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be provided.

Course Objective:

Medical foods designation comes with its own set of regulatory responsibilities. The designation of medical food by FDA implies special handling, labeling, distribution and manufacturing requirements. Manufacturers are usually worried about meeting all of FDA’s complex requirements for such products. FDA expects manufacturers to self-assure compliance status and reserves the option to audit all aspects of the manufacturing, labeling and distribution as it deems necessary.

This webinar fills the gap in knowledge in terms of the FDA expectations from medical foods and way to address common deficiencies. The case studies discussed will further highlight potential audit issues, training requirements, good manufacturing practices for medical foods, and marketing issues.

Course Outline:

  • Current FDA accepted definition of medical foods and functions foods.
  • Medical foods and dietary supplements.
  • Good manufacturing practices for medical foods.
  • Best practices for marketing and distribution.
  • Review of case-studies from unsuccessful and successful marketing of medical foods.
  • Practical tips for training of sales and marketing teams in medical foods.
  • Regulatory strategies for designating dietary supplements and medical foods.

Target Audience:

This webinar will provide valuable information to:

  • Manufacturers of medical foods
  • Physicians and hospital personnel
  • Dietary supplement manufacturers
  • Marketing and Advertising Professionals
  • Regulatory affairs professionals
  • Research analysts in the medical foods industry
  • Executive management of medical foods manufacturing companies

The Fundamentals of Profitable Compliance is the Business Model

Course Description:

The Webinar will discuss the organization’s business model and how compliance can make it more profitable.  It will demonstrate a 2D version of a business model.  Where the profitability centers are and why they are part of any strategic vision.

Course Objective:

The dynamic and changing healthcare market has opened up new rules for all types of organizations.  The rules are designed to eliminate white collar crime by meeting 7 basic steps influenced by the business model.  Most view it as a cost of doing business when it is a golden opportunity to reshape, sharpen, and increase the value of the organization for better growth and economic leverage.
Most organizations struggle with getting employees to take compliance seriously and incorporate it into their daily routine.  That is because the belief system operating is that it is simply something that has to be done not something people would want to espire to.   When compliance is viewed as a growth tool that benefits everyone, adoption occurs.

Course Outline:

  • The compliance rules
  • 2D business model
  • Corporate goals integrated into the business model
  • Steps to take

Target Audience:

Healthcare attorneys, compliance officers, billers, practice administrators, doctors who own medical practices, business associates that serve the delivery of care system.
Learning Objectives:

They can take the 2D business model and begin to address the corporate goals of the organization.  They can have more effective communication the corporate board and leaders

Affirmative Action and the OFCCP – An In-depth Primer

Course Description:

This 2-hr training will provide a comprehensive primer on affirmative action, its key principles, and current framework for developing compliant programs. It will discuss current OFCCP enforcement strategies and trends, and what it means to be a federal contractor including an organization’s responsibilities under EO 11246.

Course Objective:

This 2-hr virtual seminar will explore the history of affirmative action in greater detail. We will discuss the key principles considered when developing the legislation and regulations that provide its framework and take the time to really think about what affirmative action means for your organization today.

We will discuss the OFCCP’s mandate for compliance, key information you need to gather to ensure compliance as well as the current enforcement strategies and trends. Finally, we will discuss what it means to be a federal contractor including an organization’s responsibilities under EO 11246. All of this information is vital to your success when developing your program and helps to establish a thorough understanding of program planning requirements as you move to develop internal functional standards and guidelines.

This webinar prepares you for understanding what records to keep, what to watch out for, how technology is changing the game, and more. This training will help to prepare you for the OFCCP spotlight.

Course Outline:

  • A history in review of affirmative action.
  • Legislative and judicial history and current trends.
  • The difference between EEO and AA
  • The true meaning of affirmative action.
  • The difference between diversity and affirmative action
  • Key principles of affirmative action program design.
  • OFCCP enforcement mandate.
  • Key priorities for OFCCP.
  • OFCCP enforcement trends.
  • Recent changes in enforcement guidelines including the new scheduling letter.
  • Enforcement tools used by the OFCCP when auditing your workforce program.
  • Know how to quickly and easily determine contractor status.
  • The standard of Compliance is “Good Faith” and what that means for your program.
  • Most common compliance failures.
  • Beware of the Inference provision.
  • Most frequent Data collection and data management failures.
  • Most frequent Record keeping failures.
  • Understanding of contractor requirements for affirmative action.
  • Overview of the functional requirements for affirmative action.
  • Understanding and preparing for the analytical requirement.
  • Establishing goals.
  • Technology and how to get the most return on investment.

Learning objectives:

  • What is affirmative action and the importance of its guiding principles?
  • The legal requirements for, and the framework that drives affirmative action.
  • What the OFCCP requires of government contractors in terms of affirmative action efforts – does your current effort pass the “smell test”?
  • The focus of the OFCCP’s heightened enforcement efforts and contractor scrutiny
  • Whether or not your organization is a “government contractor” according to the OFCCP – the answer may surprise you?
  • The most frequent compliance failures, why they happen, and how to avoid them.

Target Audience:

  • All federal contractors, including those in the Health Services Industry as recently determined  by the ALJ
  • Any person within a contracting organization responsible for compliance
  • CFOs
  • COOs
  • HR and Recruiters

Validation of Cleaning: An Essential Tool to Remove Food Allergens

Course Description:

Very small amount of some allergens such as nuts can cause adverse reactions, including potentially fatal anaphylactic shock. Therefore where HACCP/allergen management plans identify cleaning as a prerequisite to ensure adequate removal of allergens, validation of cleaning regimes and on-going verification of compliance is required. This webinar will provide guidance on how to validate cleaning in terms of allergen removal and it is intended for use in all operations.

Course Objective:

Attend this webinar to understand the purpose of cleaning validation. The training session will focus on how to develop a cleaning validation plan related to food allergens, including the sequence of events likely to proceed in a cleaning validation plan, which can be tailored for specific situations. Participants will understand what to consider when choosing sampling and testing methods.
The session will provide useful example scenarios to demonstrate effective cleaning regime and non-effective cleaning regime depending on the acceptable level. On completion of the training, the participants will be able to develop and use a cleaning validation plan to demonstrate that a defined cleaning procedure is able to effectively and reproducibly remove the allergen from the specific food processing line or equipment.

Course Outline:

By attending, you will learn:
  • Cleaning validation definition
  • List of common food allergens
  • Why validate cleaning regime to show allergen removal
  • Cleaning validation plan and its characteristics
  • What to sample (Final product, Flushes, Surfaces & Personnel, Rinse/wash waters and Air)
  • Selecting the method of analysis
  • Data collation
  • Verification
  • Validation confirmation
  • Documentation

Target Audience:

  • Food processors and manufacturers
  • Owner/Partner
  • Food safety management team members
  • VPs of operation and quality in food companies
  • Hygiene Managers
  • Catering Managers / Chefs who supervise food handlers
  • Retail fresh food managers
  • Professional responsible for validation protocols
  • Local authority personnel (EHO)
  • Food safety consultants and Quality system Auditors

HIPAA 2 – What Needs to Change in Policies and Procedures

Course Description:

New rules have finalized the Interim Final Rule on HIPAA Breach Notification, but there has been an important change in how to determine whether or not a breach is reportable.  Old policies and processes must be replaced with an updated process meeting the new rule’s requirements no later than September 23, 2013.  HIPAA entities will need to follow the new rules or risk substantial fines and penalties, including multi-year corrective action plans.

 Course Objective:
HIPAA Breach Notification rules require notification of individuals and HHS when information security is breached, and the rules for determining what to report have changed.  The HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 requires all HIPAA covered entities and business associates to follow a number of steps to be in compliance.  If there is a breach of protected health information that does not meet one of the strictly defined exceptions or has greater than a “low risk of compromise,” the breach must be reported to the individual, and all such breaches must be reported to the Secretary of the US Department of Health and Human Services at least annually.
There are additional steps to take if the breach affects more than 500 individuals, including media notices and immediate notification of HHS.  For every potential breach of PHI, the entity will have to determine if the information breached meets an exception, or perform a risk assessment considering what the information was, who received it, whether it was actually viewed, and whether or not it was destroyed, and take action to notify the affected individuals if there is greater than a “low probability of compromise.”
Entities must adopt a breach notification policy and procedures to ensure accurate reporting and documentation of breaches, and must take steps to protect information from breaches by using encryption and proper disposal methods meeting Federal standards.  Entities must follow the standards and specifications of the HIPAA Security Rule to protect information from breaches and must negotiate new Business Associate Agreements to include liability for breach notification and requirements for timely reporting to the entity.
On top of all this, the landscape of information security threats and breaches is changing dramatically, requiring new kinds of security efforts and consistent application of old safeguards to protect patient information.  What used to be “good enough” is no longer sufficient to properly protect PHI.
The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and many organizations are not prepared to respond to a breach of PHI and report and document it properly.  We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations.
HIPAA Covered Entities and Business Associates need to know where and what information they have, so they can know if there has been a breach, and figure out how serious a breach may be and whom to notify if there is a chance of compromise.  We’ll discuss how to know what you have and how to decide if you need to notify.
Entities can avoid notification if information has been encrypted according to Federal standards.  We’ll talk about what information needs to be encrypted the most and how entities are doing it.  We will cover the guidance from the US Department of Health and Human Services that shows how to encrypt so as to prevent the need for notification in the event of lost data.
Online compliance Training & webinar on HIPAA 2 – What Needs to Change in Policies and Procedures will discuss how to create the right breach notification policy for your organization and how to follow through when an incident occurs.  In addition, a policy framework to help establish good security practices is presented.
We will cover the essentials of information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well.  We’ll also discuss the new penalties for non-compliance, including mandatory penalties for “willful neglect” that begin at $10,000.
We will help you understand what isn’t a breach and under what circumstances you don’t have to consider breach notification.  You’ll find out how to report the smaller breaches (less than 500 individuals), as required, within 60 days of the end of each year and you’ll know why you want to avoid a breach involving more than 500 individuals – media notices, Web site notices, and immediate notification of HHS, including posting on the HHS breach notification “wall of shame” on the Web.
We will explain, based on historical analysis of reported breaches, what measures must be taken today to protect information from the most common threats, as well as discuss information security trends and explain what kinds of efforts will need to be undertaken in the future to protect the security of PHI.  We will discuss the kinds of threats that exist for PHI and how they’re changing as the hackers gain experience and abilities, and why you need to prepare for next-generation attacks now.

Course Outline:

I.Breach Notification Laws
  • State Breach Notification Laws
  • Changes to HIPAA
  • Federal Breach Notification Law and Regulation
  • The Who, What, and How of Breach Notification
II.Preventing and Preparing for Breaches
  • Using an Information Security Management Process
  • Using Risk Analysis and Risk Assessment
  • Most Common Types of Breaches
  • Information Security, Incident, and Breach Notification Policies
  • The Importance of Documentation
III.Enforcement and Audits
IV.Future Trends and New Threats to Prepare For
  • History vs. the Future
  • Why Attack Trends Are Changing
  • Implications of New Directions in Attacks and Targets

Target Audience:

This webinar will provide valuable assistance to all personnel in:
Medical offices, practice groups, hospitals, academic medical centers, insurers, business associates (shredding, data storage, systems vendors, billing services, etc.). The titles are –
  • 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