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- Time:
- 12:30am-2:00am
- Description:
- Globalskywatch.com is a website documenting news and information about stratospheric geoengineering. there is a guest speaker and then open mike to discuss problems and concerns about the climate mitigation program.
- Time:
- 2:00pm-3:00pm
- Description:
- This training on medical diagnosis code will focus on musculoskeletal section of ICD-10-CM and the difference between ICD-9-CM and ICD-10-CM. It will help you understand the documentation that will be necessary for coders to choose the right code for medical necessity.
Why Should you Attend:
Of all of the body systems or medical specialties, this new set of diagnosis codes affects the musculoskeletal system more than any other area. There are estimates that state that 60% of the new codes are related to musculoskeletal, so for the multiple specialties that address musculoskeletal problems, these changes will change the documentation and coding process. There are many new concepts to implement for these changes to include laterality, type of encounter, and acute or chronic conditions, just to name a few.
This webinar will review the musculoskeletal section of ICD-10 to understand the differences of ICD-10 and the information needed from our providers that we may not currently receive to assign the appropriate code. The instructor will take a look at real examples of common diagnoses utilized in orthopedics today and show the current mapping to ICD-10 and break down those codes to have a better understanding of the meanings of the alpha numeric characters of ICD-10.
Coding organizations are also requiring certified coders to re-certify in order to keep a valid certification. This session will be a good education tool for several of the Chapters found in the ICD-10-CM manual to gain a better understanding to prepare coders for the examination.
Whether it is wound repairs, osteoarthritis, fractures, or external causes, this session will investigate the ICD-10-CM process in coding of musculoskeletal conditions, as well as the relationships with other body systems for proper assignment of ICD-10-CM codes.
Areas Covered in the Webinar:
Important documentation that will be needed for proper ICD-10-CM coding
What do we need to be doing now in preparation of ICD-10-CM
Review of the musculoskeletal chapter of ICD-10-CM
Review of other Chapters of ICD-10-CM that also can be used for Musculoskeletal conditions and injuries
The Gustilo Fracture Classification System
Comparison of coding rules related to orthopedics from ICD-9-CM to ICD-10-CM
Other important things to consider now for ICD-10-CM not directly related coding
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Billers
Coders
Administrators
Physicians
Physician Assistants
Podiatrists
Physical Therapists
Occupational Therapists
- Time:
- 2:00pm-5:00pm
- Description:
- This 3 hour virtual seminar on Japan regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
Why Should You Attend:
If your job responsibilities require you to have knowledge of Japan’s regulatory requirements, ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements or understand how best to consider Japan into your Global Business Strategy, then you will profit from attending our training.
This 3 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and will also add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor and applicant-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes were implemented, will also be discussed.
Who will Benefit:
Clinical / Pharma & Device personnel
Clinical Trial Project Managers
Monitors / CRAs
QA / QC Personnel
Pharmacovigilance reporting personnel
Regulatory personnel whose responsibilities require knowledge of Japan's Regulatory and Clinical Trial environment
Global Supply Chain personnel
Manufacturing personnel
Global Business Development personnel
- 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:
- 1:00am-4:00am
- Description:
- Shalonda 'Treasure' Williams is honored to invite you to the Motivation For Today Empowerment Call. Every Wednesday night at 9 p.m. EST, you will join Coach Treasure, as she is affectionately called, as she equips, inspires, motivates, encourages and even challenges you to live out your best life yet! The life where you know just who you are and what you have to offer! Each week there will be a different topic fir to empower You to T.A.P. into your true worth... Spirit! Soul! & Body! Join us on facebook for a daily dose of motivation and for call updates!
- Time:
- 2:00pm-3:15pm
- Description:
- How to Use excel spreadsheet for GXP data and reduce validation cost and time.
Why Should You Attend:
Learn how to create an Excel spreadsheet application that is GxP compliant. Understand how to validate your application with minimal documentation. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. This session includes an interactive workshop so you can learn techniques that are important to you. Bring your laptop and use Excel for your own needs.
Areas Covered in the Seminar:
Avoid 483s and Warning Letters.
Become compliance when using Excel spreadsheets for GxP data.
How to use cell and file protections.
How to use Excel’s audit trail.
Reduce validation time and costs.
Increase compliance while lowering resource needs.
Understand what validation documentation is required.
Hands on workshop to address your specific needs.
Who Will Benefit:
This session will benefit for:
Computer System users
IT
QA
Managers
Executives
Instructor Profile:
David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
He has completed more than 196 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.
- Time:
- 2:00pm-3:00pm
- Description:
- This webinar on the Foreign Supplier Verification rule, regulating food imports, will explore all 175 pages of the new rule to provide a clear idea of its new standards, criteria, definitions, and limited exemptions.
Why Should You Attend:
The Foreign Supplier Verification rule will place a new burden on importers. Importers of food will be responsible for identifying hazards and conducting various verification activities to ensure the hazards are controlled.
This webinar will discuss standards and record keeping requirements, set by the Foreign Supplier Verification rule, that if not followed could lead to refusal of a shipment or an Import Alert. The rule is incredibly detailed and replaces decades long reliance on ambiguous standards and guidance documents. This training is designed to help importers and foreign suppliers of food and dietary supplements to understand the rule and how to comply to import products once the rule goes into effect.
Learning Objectives:
-During this webinar, you will learn:
-What is a Foreign Supplier Verification Program
-How does the rule define hazard analysis
-What verification activities are required under the rule
-How to determine when the rule applies to the importer, foreign supplier, or customer of the importer
-How are dietary supplements regulated
-Other functions and unique aspects of the rule
Areas Covered in the Webinar:
-The basics of a FSVP Program
-What is an audit (who can conduct it, frequency, on-site, testing etc.)
-Hazard Analysis
-Verification Activities
-Impact of an outbreak
-Who bears what responsibility
-Exemptions
-Overlap with Preventative Controls and Produce Safety rules
Who will benefit:
-Food & beverage industry executives
-Dietary Supplement manufacturers/distributors
-Food manufacturers/distributors
-In-House Legal Counsel
-Regulatory Affairs
-Government Affairs
-Distributors and manufacturers
-Customs brokers and Importers
-FDA/Food & Drug Attorneys
Instructor Profile:
Marc C. Sanchez, represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues and is considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post.
For the food industry, Marc’s practice includes working with both the FDA and USDA on compliance, recalls, and import matters. His clients rely on his ability to equally balance market opportunity with risk exposure. The result is a philosophy that utilizes a client’s strengths in adapting to regulatory issues and market limitations. Marc’s strategy is to develop smart corporate governance along with regulatory compliance.
Topic Background:
Foreign imports of food and dietary supplements into the US will never be the same. In August the US FDA announced a new rule under the Food Safety Modernization Act regulating imports – the Foreign Supplier Verification rule. FSMA represents the first overhaul of the US food safety net since 1930s and the change to imports is now changing for the first time too.
- Time:
- 2:00pm-3:30pm
- Description:
- This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.
Why Should You Attend:
This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.
Areas Covered in the Seminar:
When to submit a 510(k) for a new or modified product.
Types of 510(k) submissions and when to use each.
What is the submission process.
What is contained in a 510(k) submission package.
How to know whether clinical data is required.
How is the submission package assembled.
User fees and 510(k) submissions.
How to interact with the FDA and the reviewer.
What to do if you make a change to your device.
Who will Benefit:
This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:
Executive management
Regulatory management
Professionals involved with premarket notification to the FDA
R&D personnel involved in approving the design of medical devices
Sales personnel involved in approving the marketing of medical devices
- Time:
- 6:00pm-8:00pm
- Description:
- Creating and delivering a quality marketing webinar takes time and effort. How can you make sure you are getting the highest possible return on your investment?
Join Ken Molay, president of Webinar Success and a former director of product marketing in Silicon Valley, as he leads you through practical tips and best practices for maximizing the ROI on your lead generation and marketing webinars.
This free, one-hour web seminar will address critical concerns including:
Design considerations in landing pages and registration forms
Tracking the effectiveness of your promotional channels
How to use social media more effectively
Coordinating promotional copy and content
Determining whether a demo is appropriate
Post-webinar follow-up techniques
The session will include time to answer your questions live and on the air. Don’t miss this opportunity to learn ways to improve the success and bottom-line impact of your marketing webinars.
- Time:
- 2:00pm-3:30pm
- Description:
- This GHS training will explain the requirements of the global harmonized standards. It will also provide you tools and tips to train employees on the updated regulation in your organization’s facilities in order to meet the December 1, 2013 deadline.
Why Should You Attend:
The Hazardous Communication Standard is one of the most cited standards that OSHA has issued and many companies have not fully complied with the new revisions to the rule’s requirements. Many do not realize that any company that has any hazardous materials or chemicals in use must comply with this standard if they have one part time employee in a calendar year. Companies that only have an office staff must also implement this program if they use hazardous chemicals. All toners used in printing from computer printers are listed as hazardous chemicals. These new rules, which came into effect on May 25, 2012, are more complicated and prescriptive than the original standard. Employers will have to train their employees on the new standard by December 1, 2013. By June 1, 2016, the new program is to be fully implemented.
This webinar will explain the requirements of the new Hazard Communication Standard and compare the old requirements with the new requirements. This webinar will focus on important part of this new standard and what is required to train our employees.
Areas Covered in the Webinar:
Overview of the old Regulation. 29 CFR 1910.1200
Basic purpose of the new GHS
The GHS change in labeling requirements
How the Material Safety Data Sheets (MSDS) will change
The new format of what will be called Safety Data Sheets (SDS)
How OSHA is planning to implement GHS
How the new GHS will effect employee training
Who Will Benefit:
Owners of Businesses
Managers
Supervisors of Employees
Safety Training Personnel
Personnel Responsible for preparing SDS sheets
Safety Directors