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.
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.
- 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?
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
- Enhance your chance getting selected by Life Science MNC’s for clinical research projects…..Learn about the posibilities!!! (onlineclinicalresearch.wordpress.com)
- Bristol-Myers Squibb Company Researcher Falsified Data in Grants and PhD Thesis (biospace.com)
- Preparing You for Careers of Tomorrow. (axonpharmatech.wordpress.com)
- Clinical Research Companies (clinicalresearchcompaniesblog.wordpress.com)
- Clinical Conductor CTMS Partners with the Greater Gift Initiative to Donate Vaccines (prweb.com)
- Clinical Trials GPS Launches New Patient Dashboard, Suggests Trials… (prweb.com)
- Investigating Research Integrity? Better start by investigating the Office of Research Integrity! (xiwang032.wordpress.com)
- More than 100 clinical trials now underway in Nebraska (nebraskaradionetwork.com)
- Tiatros Research Informs and Protects Clinical Trial Patients (tiatrosblog.wordpress.com)
- Studies from Innsbruck Medical University Reveal New Findings on Clinical Trials and Studies (hispanicbusiness.com)
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.
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.
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.
- State Feedback Controller Design Using Pole Placement Technique (matlabexamples.wordpress.com)
- ISO 13485 Standards (isocertificationias.wordpress.com)
- Physical Controls and emotional design (morganmatt61.wordpress.com)
- LRQA and TRaC Global Announce Collaborative Approach for Electro-Medical Device Sector (prweb.com)
- Why don’t medical device companies focus on the user experience? (medcitynews.com)
- Framework agreement for the medical device manufacture, assembly, packaging (hispanicbusiness.com)
- Reflection: Exploring Affective Design for Physical Controls (ashtonwolfley.wordpress.com)
- Envision Plastics Expert Announces Part Thirteen in the Series: How to… (prweb.com)
- Medical devices are in need of a health check following. (blogblooms.wordpress.com)
- Medical device startup seeks funds to advance male genital device to “Cool the Jewels” (medcitynews.com)
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.
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.
- 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.
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
- Supplement Safety Solutions Announces Nutravigilance℠ Program for Improved Adverse Event Reporting (prweb.com)
- Six Tips to Avoid “Medication Mistakes” (tevangelista13.wordpress.com)
- Bill Seeks to Sharpen FDA’s Mobile Medical App Focus (hispanicbusiness.com)
- Field Trip: Boston Medical Center’s Preventative Food Pantry (cucina-e-amore.com)
- 12 Percent of U.S. Spice Imports Contaminated, F.D.A. Finds (nytimes.com)
- Use Food for Healing? Not if the FDA Can Stop It! (anh-usa.org)
- Web Extra: FDA-approved medical food (clickorlando.com)
- FDA to get tough on drug importers, manufacturers (modernghana.com)
- Spence Masson Joins FDA Consultant and NHP Consultant dicentra as… (prweb.com)
- Free Medical Attention and Food Offered to Homeless in Huntington (wsaz.com)
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.
The compliance rules
2D business model
Corporate goals integrated into the business model
Steps to take
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
- Former Amazon Employee Explains How The Company’s Business Model Really Works (AMZN) (embargozone.com)
- How to Choose the Right Business Model to Win in the API Economy (programmableweb.com)
- Clearwater Compliance Announces Expanded 2014 HIPAA Compliance BootCamp™ Schedule (prweb.com)
- Your Business Model Is Killing Innovation (forbes.com)
- DRUCKENMILLER: Google Has The ‘Greatest Business Model’ In America And Larry Page Is ‘This Generation’s Thomas Edison’ (GOOG) (businessinsider.com)
- Why business models in education matter (frankounl.wordpress.com)
- Labor Panes Franchise Adds Professional Landscape Lighting to Their Business Model (prweb.com)
- Entrepbizmodels reviewsgeorgebock2010zottamitmassav01-110924162406-phpapp01 (slideshare.net)
- EdX: A New Business Model for MOOCs (digitalcowboys.com)
- Former Amazon Employee Explains How The Company’s Business Model Really Works (AMZN) (businessinsider.com)
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.
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.
- 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.
- 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.
- I Have a Dream vs Affirmative Action (citizens-news.com)
- OFCCP proposes new rule on affirmative action for veterans (lawprofessors.typepad.com)
- Affirmative Action: Necessary or Outdated (thevirginiaadvocate.com)
- Obama Administration Imposes Disabled Hiring Quotas On Federal Contractors (cato.org)
- EEOC and OFCCP win big in recent cases (lawprofessors.typepad.com)
- Does Egypt Need Affirmative Action? (dailynewsegypt.com)
- OFCCP Extends Comment Period/Promoting Employment of People with Disabilities (lawprofessors.typepad.com)
- Rules to improve employment of people with disabilities and veterans published today (workers-compensation.blogspot.com)
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.
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
Food processors and manufacturers
Food safety management team members
VPs of operation and quality in food companies
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
- What is Food Allergy? (sneezesnoozeclinic.com)
- Food Allergies – What You Need to Know (sarangbi101.wordpress.com)
- Bakery Warned For Not Listing Allergens (todayinfoodsafety.com)
- Trick or Treat: Food Allergies Can Ruin the Treat (allervision.wordpress.com)
- Food Recall Warning (Allergen): Tiffany Brand Strawberry Banana Sandwich Cookies Recalled due to Undeclared Milk (sys-con.com)
- An Email to the Food Standards Agency (yesnobananas.wordpress.com)
- Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies, New Life Science Webinar Hosted by Xtalks (prweb.com)
- Nut free snacks your child will love (Video) (examiner.com)
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.
State Breach Notification Laws
Changes to HIPAA
Federal Breach Notification Law and Regulation
The Who, What, and How of Breach Notification
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
Preparing for HIPAA Audits
History vs. the Future
Why Attack Trends Are Changing
Implications of New Directions in Attacks and Targets
Information Systems Manager
Chief Information Officer
Health Information Manager
- How to Be HIPAA Compliant by 2015
- HIPAA security compliance how Important is it? [Infographic]
- Law Firm HIPAA Survey Highlights Industry Commitment to Compliance with New Privacy and Security Rules Now in Effect
- Are You Ready for the Final HIPAA Omnibus Rule Changes?
- New HIPAA Requirements: What Do They Mean for VARs?