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The OSHA Voluntary Protection Program (VPP) is the highest award in Health and Safety Excellence that OSHA presents to an organization. This training program will guide attendees with best practices in implementing the OSHA VPP program. It will offer a broad overview of how to work with OSHA to achieve VPP site implementation success.

Objectives of the Presentation

• Define the key elements and sub elements of the OSHA VPP program
• Define how to get a baseline of a safety culture within your facility
• Define how to best engage employees and senior management in the safety process for VPP site implementation
• Fully comprehend the benefits of establishing a VPP mentor for VPP site implementation
• Understand how to work with OSHA to achieve VPP site implementation success
• Define how to properly fill out and submit the OSHA VPP application
• Discuss best practices and take-always in VPP site implementation
• Answer specific questions or concerns as it relates to OSHA VPP site implementation at your facility

Why Should you Attend
In this webinar attendees will understand the easy way to use tools and take-away to develop a comprehensive strategy to implement the VPP Program within an organization. The purpose of this webinar will be to give an introduction and a comprehensive overview of the OSHA VPP Program.

Areas Covered

• Introduction and overview of the OSHA VPP program
• Define the key elements and sub elements of the OSHA VPP program
• Learn to establish a baseline for a safety culture within your facility as it pertains to the VPP program
• Understand how to engage employees in the safety process for VPP implementation
• Understand how to engage supervisors and senior management in the safety process for VPP implementation
• Define best practices in implementing the OSHA VPP program

Who will Benefit

• Safety Committee Members
• Maintenance Workers
• Production Supervisors
• Plant Managers
• Occupational Health & Safety Professionals
• General Managers
• CEOs
• Business Owners
• Environmental Health and Safety (EHS) Professionals
• Corporate EHS Professionals

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HIPAA law applies to Business Associates in healthcare – BAs are organizations that create, receive, maintain or transmit Protected Health Information (PHI) – on behalf of a Covered Entity or to provide a service or function involving PHI for a covered Entity – and are directly liable for compliance with HIPAA law protecting the privacy and security of PHI.

Objectives of the Presentation

• Management responsibility
• Guide to Risk Analysis – Risk Management
• Security Rule and Privacy Rule are interconnected – Policies Required for both
• How to deal with Potential Breaches
• Understand the Business Associate Agreement (BAA) and the Subcontractor BAA

Why Should you Attend
If you are a Business Associate you must know exactly what you have to do to comply with HIPAA. But you have two hurdles.

First, your HIPAA responsibilities are new so you don’t have the HIPAA compliance background and experience of your customers – Covered Entities.

Second, you are liable for compliance with the entire HIPAA Security Rule – and parts of the HIPAA Privacy and Breach Notification Rules. But at first, second and third glance it is difficult to find your Privacy and Breach Notification Rule obligations and no one is in charge! HIPAA only directs you to identify a Security Official to develop and implement Security Rule Policies and Procedures. It gives you no direction at all about developing Your Privacy and Breach Notification Rule compliance program.

This session will explain Business Associate HIPAA compliance responsibilities in 5 steps.

There is a secret to Business Associate HIPAA compliance. The secret is – HIPAA Rules are easy to follow, step-by-step – when you know the steps.

Areas Covered
This webinar for HIPAA Business Associates will cover HIPAA law that applies to Business Associates and the top HIPAA Compliance Priorities, broken into 5 steps needed for full HIPAA compliance:
1. The HIPAA Compliance Official
Who’s in charge? – All HIPAA compliance responsibility rests squarely with top management. But authority to develop and implement a HIPAA compliance program is delegated to one or more Business Associate HIPAA Compliance Official(s). They must do more than just develop and implement Security Rule Policies and Procedures. Business Associate HIPAA Compliance Official’s duties are a roadmap to develop, implement and maintain a Business Associate’s HIPAA Compliance Program
2. Risk Analysis and Risk Management – the basis of HIPAA Compliance broken down into its 3 basic parts and explained step-by-step
3. Understand and implement the interconnected Business Associate Security Rule and Privacy Rule Compliance responsibilities with appropriate Policies and Procedures
4. Learn how to investigate, assess and document Potential Breaches and if necessary, make notifications required by the Breach Notification Rule
5. Understand Business Associate Agreements with a Covered Entity and a Subcontractor Business Associate. Write your own Business Associate Agreement, recognize red flags, and avoid making your Subcontractor Business Associate your agent under the Federal Common Law of Agency by mistake

Who will Benefit

• C-Suite Executives
• Compliance Official
• Chief Information Security Officer
• Risk Management Director
• HIPAA Compliance Official
• HIPAA Privacy Officer
• HIPAA Security Officer
• Information Technology Supervisor
• Healthcare Marketing Manager
• General Counsel
• Attorney
• Certified Public Accountant

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All importers and producers of processed food products must be aware of the new regulations and apply it in their labels for final consumer. Attend the webinar to know and understand the Mexican labeling standard as well as and the new requirements regarding the use of Front of Pack icons and the voluntary request of a nutritional Logo. The speaker will also explain the steps to follow in order to gain an ‘organic’ status.

Objectives of the Presentation

• Understand the application of NOM-051-SCFI/SSA1-2010
• Know the new mandatory Front of Pack labeling
• Know about the Regulatory Competent Authority in Mexico for processed food (RCA)
• Have general knowledge about other further Mexican Standards regarding labeling requirements
• Know times for response from the RCA
• Know about official web sites to get information
• Learn about the steps to get the status “organic”

Why Should you Attend
U.S. exports of agricultural products to Mexico rose 7% to US$19.3 billion in 2014, ranking it 3rd in the world after China and Canada. Also in 2014, U.S. exports of consumer-ready food products represented 48% of the agricultural total, or US$9.2 billion, an increase of 12% from 2013 and a new record high. Mexico remains the 2nd largest export market for consumer ready products. Besides this, consumer interest on health products, natural products and organic products require accomplishment of specific rules in order to address special characteristics.

All importers and producers of processed food products must know and apply these regulations in the labels of their products intended to be imported and commercialized in Mexico.

Mexican requirements for specific commercial information which must be marked on products sold to consumers may differ based on product. In general, specific labeling requirements for prepackaged food and non-alcoholic beverages are included in NOM-051-SCFI-1994 “General Specifications for Labeling Prepackaged Foods and Non-alcoholic Beverages”. The Mexican importer is responsible for making sure that the products comply with the NOM. For this reason, U.S. exporters should seek informed advice from an agent, distributor, importer or local consultant familiar with the market requirements.

The changes established in the regulations are mandatory for food and non-alcoholic beverage products. The amendments to the regulation also include a ‘voluntary nutritional quality seal’ that would be awarded to those products that comply with specific requirements established in the new regulation and by request of the manufacturer of the product.

Areas Covered
Our featured presenter, Esther Diaz, who worked in Mexican Federal Government at Health Ministry, will discuss:

• Description of the Mexican Regulatory Authorities for human food
• Overview of the general Mexican Regulatory Framework
• Description of the amendments Regulation of Sanitary Control of Product and Services
• Description of Mexican Standard NOM-051.SCFI/SSA1-2010
• Overview of further Mexican Official Standards regarding labeling requirements
• Special considerations for food supplements
• Procedure for getting the “organic” permission

Who will Benefit

• Food industry professionals
• Quality Assurance and Food Safety Managers
• R&D Managers
• Food Scientist
• Marketing Managers
• Students
• Marketers
• Customs agents

Topic Background
In 2013, the country passed a comprehensive obesity prevention strategy that included awareness-raising, healthcare, regulatory and fiscal initiatives.

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Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

Objectives of the Presentation

• Steam sterilization on a microbial level
• Autoclave Performance Qualification expectations
• Regulatory and GMP requirements for steam sterilization
• Process verification tools for use in an autoclave
• Common questions, problems and cGMPs

Why should you Attend
Sterilization process parameters will be laid out as a basis for conducting autoclave performance qualification studies. Whether qualifying a new autoclave installation or continuing maintenance of existing equipment, there are specific expectations for steam sterilization that must be met.

Regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators will be provided, along with definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

Common questions and hot topics in industry will be presented to demonstrate the practical application of understanding steam sterilization. These points exemplify how the knowledge allows for efficient troubleshooting of unexpected events and for improving processes in an autoclave.

Areas Covered

• Definitions
• IQ/OQ/PQ Requirements for Autoclave Validation
• Autoclave Monitoring Tests
• Biological Indicators – How and When to Use
• Verification vs. Revalidation

Who will Benefit

• Quality Assurance Managers
• Supervisors
• Validation personnel
• Sterility Assurance personnel

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The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.

Per FDA and ICH guidelines, a clinical protocol should be based on sound scientific rationale, conducted in a suitable population, include all appropriate procedures that help meet the endpoints, and be protective of study participants both physically and ethically. On an average about one of every three clinical trials fail to meet their primary goals due to poor design, faulty statistical strategy, lower recruitment, poor management of resources, and regulatory issues. Most of these causes of failure can be mitigated by a well-designed clinical trial protocol.

Irrespective of the Phase of a study, clinical trial protocols should follow some common rules. These rules are based on regulatory requirements, scientific logic, and practical experience. This webinar will walk the attendee through 10 critical steps in the development of a clinical protocol. Step-by-step instructions will be provided, with case studies to emphasize the common mistakes and potential solutions.

Why Should you Attend:
If you are involved in writing a clinical trial protocol, this webinar will provide valuable suggestions about various aspects of a clinical protocol from initial synopsis to various elements of the protocol, role of various personnel in finalizing the protocol, and troubleshooting common issues. The basic elements of a clinical trial protocol, the dos and don’ts of clinical trial procedures, development of a new protocol, amending protocols, scientific and ethical review of clinical protocols will be discussed. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.

Objectives of the Presentation:
At the end of this webinar, you would understand:

• The overall structure of a protocol and regulatory requirements
• Identify who contributes to the protocol development and amendments
• The element of a protocol such a background scientific rationale, design (single blind, double blind, randomized, etc.), primary and secondary endpoints, inclusion/exclusion criteria, the Schedule of Events, adverse event management, statistical parameters, informed consent, and study synopsis
• Practical issues with protocol writing such a differences in various phases of clinical trials, the protocol review process, using key opinion leaders, and using public resources and templates
• Common issues with FDA and IRB approval of clinical protocols.

Who can Benefit:

• Sponsors of INDs
• Regulatory Affairs Professionals
• Senior Management Executives (CEO, COO, CFO, etc)
• Drug Discovery and Development Professionals (R&D and CMC)
• Clinical Trial Managers
• Project Managers and Clinical Trial Specialists
• Regulatory Compliance Associates and Managers
• People investing in FDA-regulated product development projects.

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This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.

The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global medical device laws, regulations and regulatory requirements have become increasingly important in our competitive global market. Global regulations of medical devices are rapidly evolving, integrating the regulatory systems of the advanced medical device regulations. To be able to achieve sustainability and to remain sustainable and competitive in Asian medical device markets, it is necessary to get familiar with applicable and relevant laws and regulations governing medical devices, further streamlining the regulatory process. To do so, we should understand the differences in regulatory frameworks (regulatory requirements and compliance) in a sustainable and effective way.

This webinar is intended to help you understand and accurately interpret applicable laws and regulations governing medical devices in China, Hong Kong, Japan and Korea.

This webinar will help you understand and expedite the registration process for your devices in these Asian countries.

Speaker will present laws and regulations governing medical devices in China, Hong Kong, Japan and Korea. It is designed to help medical device industry implement practical, actionable and sustainable strategy for device registration in these countries and further to streamline their business planning and registration process in Asian countries.

Objectives of the Presentation:

• Laws and regulations governing medical devices in China, Hong Kong, Japan and Korea.
• Definitions and classification
• Regulatory framework for medical devices in China, Hong Kong, Japan and Korea
• Regulatory requirements for medical devices including in vitro diagnostic devices in China, Hong Kong, Japan and Korea
• How to identify and address the regulatory requirements
• How to establish and maintain systematic methods to meet the regulatory requirements
• How to streamline the regulatory process
• Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner.

Who can Benefit:

• Regulatory Affairs Managers, Directors and VPs
• Clinical Affairs Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Compliance Managers and Directors
• Sales and Marketing Managers, Directors, and VPs
• Complaint Handling and Risk Management Managers and Directors
• Site Managers, Directors, and Consultants
• Senior and Executive Management
• Compliance Officers and Legal Counsel
• Business Development Managers, Directors, and VPs

Live Session – How it works

• We will send Username and password 24 hours prior to webinar at your email address.
• Webinar presentation handouts will be shared in pdf format, a day before live presentation.
• Use the login details to participate in sessions.
• Clear out your queries through interactive Q&A chat boxes with the speaker.
• We need to know your experience, so please don’t skip to provide us with your overall presentation feedback.
• Get certification of attendance.

Recorded Session – How it works

• Once you purchase a webinar you will receive username and password at your email address.
• Use the login details to view recorded webinars.
• Presentation handouts will also be shared in pdf format.
• Access to the recording is valid only till 6 months starting from the date of purchase.
• Get certification of attendance.

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Food Laws and Regulations in México are numerous and complex. Mexican food marketplace offer many possibilities but due to regulatory requirements, it translates into a big challenge in order to be compliant with all of them. In this webinar we’ll overview the general requirements and applicable laws in order to commercialize food products in Mexico.

Objectives of the Presentation

• Mexico Food standards/ laws
• Inspection bodies in Mexico
• General requirements to commercialize food and beverages in Mexico
• Legal structure to comply

Why Should you Attend
Processed food and beverage is subject of compliance before Minister of Health in Mexico and other authorities. The numerous laws add complexity in order to successfully explore the marketplace. Counting with the basic knowledge of laws and procedures not only enhance good practices but also guarantees the correct insertion in the market and in the consumer choice. At the conclusion of the webinar you will acquire basic knowledge of the Mexico Food standards regulation applicable to commercialize food and non-alcoholic beverages.

Areas Covered

• Legal structure for food compliance in Mexico
• Inspection bodies responsible for Food and Non alcoholic beverages compliance
• Overall food standards for Mexico
• Main standards applicable for Food and Non alcoholic beverages
• Commercialization of food and non-alcoholic beverages in Mexico
• Labeling general requirements
• Advertising general requirements

Who will Benefit

• Food and non alcoholic beverages distributors and manufacturers
• Regulatory compliance specialists
• Marketing program managers
• Food industry professionals
• Quality Assurance and Food Safety Managers
• R&D Managers
• Food Scientist
• Marketing Managers
• Students
• Marketers
• Customs agents

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This webinar provides the guidance needed to use Web Sites and Social Media in healthcare and stay compliant with HIPAA. The HIPAA Rules, HHS/OCR guidance, Resolution Agreements provide a simple, easy to use blueprint using your Web Site and Social Media to engage patients and comply with HIPAA.

Objectives of the Presentation

• A clear explanation of the HIPAA Rules that apply to Health Care Provider Web Sites and Social Media like your practice’s Facebook page
• What to do – and not do – about Patient Reviews
• How to keep your Web Site and Social Media dynamic, effective and follow simple HIPAA Rules
• HIPAA Rules for Web Sites, Social Media and Patient Reviews are clear, unequivocal and easy to follow. It only takes one look at a Health Care Provider’s Web Site or Social Media page to find violations
• What to look for on your Web Site or Social Media site – how to identify violations – and how to fix them
• How to use advice from marketing professionals in a way that complies with HIPAA. Remember it is the Covered Entity who is responsible for HIPAA compliance – and liable for violations

Why Should you Attend
The HIPAA Rules, HHS/OCR guidance and settlements reached by OCR following investigations of violations provide a simple, easy to use blueprint for engaging patients and attracting new patients while avoiding HIPAA violations and liability.

This session will explain the HIPAA Rules for Web Sites, Social Media and Patient Reviews – how you can do what you want to do and comply with HIPAA. HIPAA Rules are easy to follow, step-by-step – when you know the steps.

Who will Benefit

• HIPAA Compliance Official
• HIPAA Privacy Officer
• HIPAA Security Officer
• Health Information Technology Supervisor
• Practice Manager
• Risk Manager
• Dentist
• Optometrist
• Chiropractor
• Physical Therapist
• Podiatrist
• Hospital Trustees
• C-Suite Executives

Topic Background
Patient Engagement is a cornerstone of quality patient care and, along with New Patient Attraction keeps your practice strong and helps it grow. Health care provider Web Sites and Social Media Web Sites like Facebook are essential to engage patients and attract new patients of all ages from Millennials to senior citizens. Provider Web Sites and Social Media pages are inexpensive, easy to build and universal today.

A 2018 survey found 72% of respondents use Patient Reviews posted on the Internet to choose a new provider, up from 25% in 2013.

However, Patient Engagement and New Patient Attraction through Web Sites, Social Media and Patient Reviews are covered by HIPAA Rules. The rules are easy to follow when you know what they are – but highly visible violations are widespread on the Internet.

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This webinar explains the regulatory requirements of OSHA’s recordkeeping standard; Part 1904 – recording and reporting occupational injuries and illnesses. Attendees will learn which types of injuries and illnesses are recordable, how to make entries on the OSHA 300 recordkeeping forms and how to complete the annual summary form. This training will cover critical aspects of OSHA recordkeeping and its requirements, to be compliant with OSHA regulations. Employers with covered establishments located in all states must submit their 300-A Summary data by the July 1, 2018, deadline – not just employers in states that have adopted OSHA’s final rule requiring the submissions.

Objectives of the Presentation

• What needs to be recorded – and what forms to use
• Understanding of the 1904.41 requirements
• The rules regarding location, retention, and maintenance of records
• How to identify work-related incidents and the general reporting criteria
• Which injuries need to be recorded and which ones are exempt
• Which OSHA files must be made available to employees
• Dealing with injuries of independent contractors and temporary workers
• How OSHA differentiates between injury or illness
• Which industries are required to report and which ones are exempt
• Setting up an occurrence reporting system that will ensure your logs are right
• The national accentuation program on injury and illness recordkeeping
• Properly posting and electronically filing your recordkeeping data
• The most common mistakes companies make when filling out their logs – and how to avoid them!

Who will Benefit

• Safety personnel
• Occupational Health Personnel
• Human Resources Administrators
• Supervisors
• Managers
• Small Business Owners
• IT, data, quality staff and other members responsible for maintaining the OSHA 300s
• Nurses
• CEO or Company Executive
• Compliance & Safety Officer
• Director of Risk Management
• Director of Human Resources
• Regulatory Compliance Agent
• Risk Advisor-Insurance Companies
• General Contractors
• Process Technicians
• Warehouse Managers
• General Employees
• Construction Contractors, Nurses, Physicians
• HR Managers, Safety Managers, Facility Managers
• In-house Attorneys, Risk Managers, Business Owners

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