Regulatory Guide for Medicare Claim Management of ADRs (Additional Development Requests)
Elisa Bovee
60 Min
Product Id: 705270
This training program will provide an overview of how the interdisciplinary team can successfully navigate through Medicare claim reviews and request for additional developmental requests (ADRs). This course will offer a step by step approach to ensure accurate appropriate reimbursement.
FDA vs Health Canada
Rachelle D Souza
60 Min
Product Id: 704862
This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.
Regulatory Compliance for Dietary Supplements in the US, EU, and Canada
Derrick Swint
90 Min
Product Id: 705238
This training program will offer an understanding of how dietary supplements are regulated differently in the US, EU, and Canada, with a focus on challenges and opportunities in each of these regions. The course will provide an overview of the regulatory agencies that govern requirements within each region and the role that each agency plays in setting and enforcing rules for dietary supplements.
How to Transfer Non-Compendial and Developed QC Procedures - ICH and USP Guidelines
Barbara Berglund
90 Min
Product Id: 701845
This webinar will explain ICH and USP guidelines for validation and how to apply ICH guidelines for method transfer and how to establish boundaries.
Developing a Formal First Aid, CPR, AED Training Plan
Joe Keenan
90 Min
Product Id: 705264
This webinar will discuss the importance of developing a formalized first aid, CPR, and AED training plan. It will review OSHA standards for emergency response and offer guidelines for first aid, CPR and AED administration.
Legal and Practical Guidelines for Dealing with Psychiatric Disabilities at Work
Janette Levey Frisch
90 Min
Product Id: 705103
The Americans with Disabilities Act requires employers to provide reasonable accommodations to qualified individuals with disabilities, including those with psychiatric impairments that substantially limit their major life activities. This webinar will discuss an employer’s responsibilities in the workplace and help you take your first steps toward preventing tragedy, ensuring a productive, engaged workforce and safe workplace, and that you are protected against legal liability.
Creating and Maintaining an Effective and Efficient Technical Training Programs
Ginette M Collazo
90 Min
Product Id: 704373
This training program will analyze key elements of training programs in regulated environment. It will also list key performance indicators related to training and offer best practices for developing technical training programs to improve their effectiveness.
OASIS-C2 - Home Healthcare; Quality Measures and their Impact in 2017
Laura S Hargraves
75 Min
Product Id: 705140
This OASIS-C2 webinar will review the new proposed measures, how they work and how to correctly document the data to ensure better outcomes and better rating for your organization.
Understanding the Basics of the FDA's New Labeling Requirements
Derrick Swint
90 Min
Product Id: 705235
The online training will offer food manufacturers a 360 degree approach to food nutritional labeling from a past, present, and future perspective.
Exporting to Canada Procedures and Documentation
Jan Seal
90 Min
Product Id: 703136
This training on export compliance will help you understand documentation and procedures to assist in expediting clearance of commercial goods through Canada Border Services Agency.
Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach
Saeed Qureshi
120 Min
Product Id: 705256
This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.
TSCA Awareness Program for 2017
Joe Keenan
90 Min
Product Id: 705251
This training program will clearly define all requirements of the Toxic Substance Control Act (TSCA). It will discuss best practices for developing TSCA written plans and TSCA training plans, as well as breakdown all components of the TSCA.
Medical Device vs. Consumer Device: Leveraging Technology to Help Patients and Caregivers
Tom Kramer
60 Min
Product Id: 705223
This training program will provide an understanding of key areas of design focus for medical wearables. Attendees will learn best practices to implement product development plan that apply to medical devices.
3-Hour Virtual Training: Lean and the Manufacturing Process
Charles H Paul
180 Min
Product Id: 705229
Lean implementation is not confined to just manufacturing. It can be appropriately applied throughout the organization in all functions. This virtual training program, however, focuses on manufacturing, where lean was born. The difference between this treatment of lean application and others is that we have imbedded the concept of GMP and compliance into our lean model to make it particularly applicable to the life sciences.
Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies
Peggy Berry
90 Min
Product Id: 705255
This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
UDI in the EU – A Preliminary Look
Daniel O Leary
90 Min
Product Id: 704854
Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.
Cardiology Mid-Year Coding Update 2017
Terry Fletcher
60 Min
Product Id: 705208
Cardiology Coding 2017, mid-year update. We will cover in office diagnostics, to include any updated rules on EKGs, Holters, Stress Tests. Look at the new coding for 2017 Moderate Sedation Codes, and how they have impacted the first half of 2017. This webinar will also discuss on the new E/M symbols, rules, and new codes and deleted symbols that will impact provider reimbursement, for Cardiology services.
The Canadian Food Label
Derrick Swint,Abdesselam Benlembarek
90 Min
Product Id: 705209
The food label is one of the most important tools Canadian consumers can use to make informed choices about healthy and safe foods. Canadian food legislation has specific requirements for food manufacturers regarding what to include on a food label and how it should be presented. This course will review the basic requirements of the Canadian Food label, including requirements for the location and size of the common name, net quantity declaration, list of ingredients and allergen labeling, identity and principal place of business, date markings, nutritional labeling, bilingual requirements, irradiation, and sweeteners. For manufacturers of food products for consumption in Canada wishing to ensure compliance to the latest nutritional labeling standard, this course offers an overview of the necessary elements to ensure compliance.
Food Safety and Quality Management - Effective Incident Tracking
Felix Amiri
2.5 hrs
Product Id: 705204
This Food Safety and Quality Management training will provide guidance on methods for conducting effective incident tracking. Attendees will learn how to analyze and utilize incident tracing information and data to the benefit of your food business.
Medical Device Cybersecurity Following New FDA Guidance
Edwin Waldbusser
60 Min
Product Id: 705200
This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.







