This training on FDA’s regulation of cosmetic labeling will detail the labeling requirements for manufacturers, packers and labelers of cosmetic products in the United States. It will also cover general labeling and ingredient-related limitations that federal laws and regulations place on cosmetic products.

Why Should You Attend:

Federal law and FDA regulations dictate the precise requirements for cosmetic products that are marketed and sold in the United States. To this end, FDA regulations require certain information and specific placement on cosmetic labels.

Unlike food products, cosmetics are often sold in decorative containers or sometimes without a package at all. Accordingly, it is important to consider the effect that different types of packaging may have on compliance with FDA label regulations.

This session is designed for manufacturers and labelers of cosmetics in the United States and is designed to aid both domestic and foreign entities in ensuring compliance with FDA regulations. This session will cover the requirements of the Federal Food, Drug and Cosmetic Act ("FFDCA") and accompanying regulations to help those in the cosmetics industry understand the key areas of FDA compliance with respect to cosmetic labeling. We will discuss FDA regulations pertaining to cosmetic labeling, as well as the cosmetic labeling manual. Within the context of labeling, we will briefly cover the FDA's regulation of cosmetic ingredients and how these ingredients must be displayed on product labels. Further, we will examine how failure to comply with these requirements may lead to FDA enforcement actions. Finally, we will open the session up to questions to allow the attendees to voice any concerns related to the issues surrounding the FDA's regulation of cosmetic labeling.

Areas Covered in this Webinar:

• Detailed overview of the FFDCA and FDA regulations with respect to cosmetic products
• What FDA expects from manufacturers and labelers, as far as ingredients and labeling of cosmetic products that are offered for sale in the United States
• Overview of how to label cosmetic products
• Examination of the various types of outer packaging that may be used for cosmetics products
• How failure to comply with the guidelines may affect the manufacturing unit
• Examples of FDA warning letters issued to cosmetics companies and other enforcement measures

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.

Why Should You Attend:

On a regular basis, there are assays that get developed that have a clear utility in the clinic. However, what may be practical within a research context may not be practical within a clinical context. In addition, these assays have to be able to handle clinically relevant samples, which often differ from the samples used in research studies. Unless an assay can give clinically actionable results in a clinical laboratory, whatever utility the assay may have will be useless to clinical practioners, who have different demands than research laboratories.

In this 60-minute training, you will learn what needs to be done to an assay to make sure it is ready for the clinic and how to validate such changes. In addition, you will learn how to select a clinically relevant population for a given assay, validate the assay within such a population and how to select Gold Standards for comparison. Finally, you will be able to develop clinical quality monitoring standards to make sure the assay remains relevant in a clinical context.

Area Covered in this Webinar:

This webinar will help you learn how to validate assays for clinical diagnostics. The webinar will include the following critical information you will need:

1. What are the key differences between a research assay and a clinical assay?
2. How to make sure an assay can regularly be performed by a medical technologist, and how to validate those changes?
3. How do you find clinical relevant samples to test your assay against?
4. How to find a Gold Standard assay and develop a validation plan against it?
5. How to validate an assay for clinical use?
6. How to develop a clinical quality plan to make sure the assay remains valid?

Overview: Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. A fun way to present this serious topic!! 483’s and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection.

Areas Covered In the Session: This presentation will use humor to describe:
Why the FDA issues such citations
What is a 483 and what does it look like
What is a Warning letter and what does it look like
What is the difference between a 483 and a Warning Letter
What they mean for your company
How to respond to 483s and Warning Letters to avoid escalation by the FDA
How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters

Who will benefit:
CEO
Regulatory VP
Quality VPs
IT VPs
Regulatory Affairs Professionals
Quality Managers
Quality Engineers
Small Business Owners
GxP
Consultants

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Event Link -http://bit.ly/10zLRX0

Overview: Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry.

This Webinar will provide a broad overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E-Imports and Exports. Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code. The affirmation of compliance should include: importer registration number, foreign establishment registration number and name of U.S. agent, medical device listing number, and Premarket Notification 510(k) or Premarket Approval number, if applicable. For exporting, while FDA does not place any restrictions on the export of devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). Learn the process for unapproved and approved medical devices to be exported and the documentation process involved.

Areas covered in the session:
Examine the import and export requirements for medical devices
Introduction to FDA references and guidance documents related to import and export requirements
Understand the regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S.
Import Alerts
Recordkeeping requirements and your responsibilities
How to export unapproved and approved medical devices

Who will benefit:
All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the export/import process
Regulatory Affairs
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Engineering/Technical Services/Operations
Consultants

David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Event Link - http://bit.ly/19wavgy

Overview: Each FDA center has different guidelines and processes to follow in order to have a successful submission for the regulatory review of the medical product. The submission process for drugs, biologics and medical devices is rigorous and has specific timelines and standards to follow.

The agencies (FDA, EMEA) encourage electronic submissions and they have developed data standards and other guidelines. The Common Technical Document (CTD) describes the modules, sections and documents to be used by an Applicant for a Marketing Authorization for a medical product for human use ( EU, Japan and US). Different Standard Development Organizations (HL7, ISO, CDISC, ICH) work to produce and harmonize standards nationally and worldwide to improve regulatory submissions.

Why Should You Attend: This webinar will provide the new and expected guidances on data standards and electronic submissions for drugs and medical products. We will explain what are the policies and the requirements for submissions and standards for drugs in US and globally and how it affects healthcare/drug industry to adopt them.

All functional groups and professionals who have responsibility in the submissions and approval process for medical products and need to have an overview of the field should attend.

Areas Covered in the Session:
Overview: Approval Process for Drugs, Biologics and Devices
Submission Requirements & Guidances, FDA
Electronic Regulatory Submission & Gateway, FDA
e-Submissions, EMEA, EU and globally
International Conference on Harmonization (ICH)
Electronic Common Technical Document (eCTD), ICH
eCTD Guidance and Specifications, FDA
Health Level 7 Regulated Clinical Research Information Management
Clinical Data Interchange Standards Consortium, (SDTM, SEND, ADAM)
Biomedical Research Integrated Domain Group(NIH, FDA, CDISC, HL7)
Benefits and Challenges with Data Standards worldwide

Who Will Benefit:
Management (Pharma, Biotech)
Policy analysts
Government officers
Health IT Managers and Analysts
Research and Development (Pharmaceutical, Academia)
Regulatory Affairs personnel
Quality assurance/quality control personnel
Auditors and inspectors
Entrepreneurs Investors

Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist.
Dr. Makrodimitris is the principal for K Makrodimitris that specializes in Health IT & BIO business development, eHealth education, Health Information policy.

He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (devices, foods, drugs, personalized health).

NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Event Link - http://bit.ly/11OTIGT

Overview: When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?

If you send a letter to a customer that says, "We found a problem, but, not to worry, we will fix it for you!", you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may not need to report, but you must keep a record of your decision. You need to make sure you know the when to report and when a record is adequate.

Why should you attend: An FDA Inspection will check for Corrections and Removals during an inspection. Often Inspectors will check specific actions, since they will monitor your website and usually get a copy of letters you sent to customers. If you send a letter that notifies your customers of a problem, it will almost certainly get to a competitor who will send a copy to FDA. If you didn’t report to FDA, the Inspector will ask for your records documenting the reason not to report.

This webinar will clarify your obligations for corrections and Removal under Part 806. You will learn:
The requirements of Part 806 including the difference between reports and records
The difference between a correction and a removal and how to report them
The exceptions in Part 806 and how to apply them to make the reporting decision
What an Inspector will look for in a QSIT inspection
What to look for in an effective program and how to ensure your program makes the grade
The results of Warning Letters and how you can avoid some of the same issues
The relationship with design changes and the potential need to update a 510(k)

Areas Covered in the Session
The basic requirements of Part 806
When to report
Exemptions that you may apply
Market withdrawal
Routine servicing
Stock recovery
Reporting under Part 803 - Medical Device Reports
Reporting under Part 1004 - Repurchase, Repairs, or Replacement of Electronic Products
The requirements of a report and the timing
The requirements for records when you don’t report
The expectations of a QSIT Inspection
Elements of a robust system
How to check your system for compliance
Recalls
Design changes and potential 510(k) submissions
The current guidance
The draft guidance

Who Will Benefit:
Quality Professionals
Regulatory Professionals
Risk Management Specialists
Complaint Managers and Specialists
Compliance Officers
General/Corporate Counsel
Regulatory/Legislative Affairs Professionals

Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management.

NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Event Link - http://bit.ly/14qObUD

Overview : This program will provide an Understanding of the National Labor Relations Act, providing insight into employee rights and pitfalls to be avoided by employers. We will discuss how unions organize, the impact of unionization on a business, the rights of workers to act concertedly without a union, and similar matters.

Why should you attend: Unionization in the private sector has contracted significantly over the last several decades, though it has remained reasonably widespread in the public sector. Unions have been facing hard times with the move of some states to curtail the bargaining rights of state employee. Unions in the private sector are looking for new ways to grow and strengthen their bargaining power.

For most employers, unionization is a real threat to be avoided. This webinar will discuss how the NLRA works, the nature of workers’ rights, how unions organize, and things employers can do to lawfully remain free of unionization.

Areas Covered in the Session:
How the NLRA works
How unions organize employees
Ways to avoid unionization
Rights of employees to engage in lawful concerted activities
Limitations imposed on employers

Who Will Benefit:
HR Directors
Persons administering COBRA benefits
Personnel involved in labor and employment matters

Price: $145.00
Contact:
Russel Stuart
Phone: 1800-385-1627
E-Mail: webinars@trainhr.com

Overview : This program will provide an Understanding of the National Labor Relations Act, providing insight into employee rights and pitfalls to be avoided by employers. We will discuss how unions organize, the impact of unionization on a business, the rights of workers to act concertedly without a union, and similar matters.

Why should you attend: Unionization in the private sector has contracted significantly over the last several decades, though it has remained reasonably widespread in the public sector. Unions have been facing hard times with the move of some states to curtail the bargaining rights of state employee. Unions in the private sector are looking for new ways to grow and strengthen their bargaining power.

For most employers, unionization is a real threat to be avoided. This webinar will discuss how the NLRA works, the nature of workers’ rights, how unions organize, and things employers can do to lawfully remain free of unionization.

Areas Covered in the Session:
How the NLRA works
How unions organize employees
Ways to avoid unionization
Rights of employees to engage in lawful concerted activities
Limitations imposed on employers

Who Will Benefit:
HR Directors
Persons administering COBRA benefits
Personnel involved in labor and employment matters

Price: $145.00
Contact:
Russel Stuart
Phone: 1800-385-1627
E-Mail: webinars@trainhr.com

Overview : This program will provide an Understanding of the National Labor Relations Act, providing insight into employee rights and pitfalls to be avoided by employers. We will discuss how unions organize, the impact of unionization on a business, the rights of workers to act concertedly without a union, and similar matters.

Why should you attend: Unionization in the private sector has contracted significantly over the last several decades, though it has remained reasonably widespread in the public sector. Unions have been facing hard times with the move of some states to curtail the bargaining rights of state employee. Unions in the private sector are looking for new ways to grow and strengthen their bargaining power.

For most employers, unionization is a real threat to be avoided. This webinar will discuss how the NLRA works, the nature of workers’ rights, how unions organize, and things employers can do to lawfully remain free of unionization.

Areas Covered in the Session:
How the NLRA works
How unions organize employees
Ways to avoid unionization
Rights of employees to engage in lawful concerted activities
Limitations imposed on employers

Who Will Benefit:
HR Directors
Persons administering COBRA benefits
Personnel involved in labor and employment matters

Price: $145.00
Contact:
Russel Stuart
Phone: 1800-385-1627
E-Mail: webinars@trainhr.com

Overview : There's a lot of discussion of "CCOS" these days (Compensation Cost of Sales). It's a very important metric, but very difficult to compare from one company to the next, even within the same industry. Early stage companies tend to have a higher sales comp cost % revenue; higher margin businesses tend to be willing to pay more for the next sale; complex sales organizations with specialized channels tend to have a lower sales comp cost % revenue once the channels are optimized, but higher early in the deployment of the channel strategy.

So, what analysis can shed light on these differences, how do you look at comparisons, and once you have your baseline established, what can you do to manage down your sales compensation cost?

Why should you attend: Is your sales compensation cost appropriate for your business? Is each of your sales teams/channels adding value? What about your top performers vs. your under-performers? Where is the money going, and what is the business getting for that sales comp spend? Understanding the structure of your compensation spend is vital to ensuring the sales function is creating value for the business.

Areas Covered in the Session:
Correct measurement of the cost of the sales team vs. productivity - what's in the numerator and what's in the denominator?
Specific analyses to be completed, illustrated by a case example
Follow the money, by incentive measure and sales team
Understand the cost of the sales force by performance level
Understand the cost by channel
Trending aggregate cost of comp over time
Typical patterns in CCOS
Best ways to improve CCOS
Common misconceptions about CCOS
What to expect as the business matures

Who Will Benefit:
HR Generalists supporting sales teams
Compensation Managers
Sales Leaders
Finance Leaders
Business Owners

Price: $145.00
Contact:
Russel Stuart
Phone: 1800-385-1627
E-Mail: webinars@trainhr.com