You are living in the NEW era of money where money can literally be made out of thin air.

But do you know the rules? And like they say, if you don't know the rules, how can you play the game?

Register for this webinar and you'll know how to play the game. Registration is ABSOLUTELY FREE, but space is limited.
https://attendee.gotowebinar.com/register/2940194496884120832

Only 100 seats available, and you DON'T want to be left out of the game.
https://attendee.gotowebinar.com/register/2940194496884120832

New For 2013!

The Internet Marketing Strategies To Kick Start Your Online Business!

A Series Of Live Coaching Calls Hosted By InternetBusinessKickStart.Com

Live TeleSeminar #1:
Five Ways To Build Your Audience Online

One of the first things you'll want to do when starting a business on the web is start attracting an audience for your product or service.

The first step to building your customer base is creating an opt in email list that you fully own, since this will provide the maximum number of sales conversions over any other online business promotion.

Here are a few of the topics we're going to cover in Coaching Call #1

The tools you'll need to create an effective email list
Attracting list sign ups through content marketing
How you can build and convert a Twitter following to your list
How to measure and adjust your marketing for maximum opt ins
Keeping your list engaged so they stay subscribed and convert to sales

Plus we'll be taking your questions in our Q+A session during the teleseminar.

Places are free but strictly limited on a first come first serve basis, so make sure you don't miss out. Register right away and learn the internet marketing strategies that will kick start your internet business in 2013!

Register at http://internetmarketingstrategies2013.eventbrite.com/

Once you have registered you'll be sent a confirmation email with details on how to join the conference

During this live training event, you'll discover and learn (for FREE):

The step-by-step blueprint that
Danny used to grow Firepole Marketing
from *nothing* to a multiple-six-figure
business (that you can use, too!)

The most important traffic strategy that
*real* experts use (but aren't teaching)

Why being authentic and doing what
you’re passionate about is the BEST
way to make the MOST money (and the
*only* safe strategy in 2013)

The counter-intuitive (but totally legit)
way to get better results by doing much
*less* work (this is the exact OPPOSITE
of what most “gurus” are teaching!)

The two most important metrics for any
online business (hint: *neither* of them
is traffic)

How you can *realistically* replace a
full-time income THIS YEAR

Customers have more access, more information and more insights into your products and services than ever before – long before and after the point of purchase. Yet, today’s channel-specific marketing practices are too slow and too limiting to effectively decipher the customer buying cycle, especially as consumer expectations continue to escalate and competitive offers become more relevant and targeted. Join guest speaker Senior Forrester Research Analyst, Rob Brosnan, as he shares insight into how bringing together data across paid, earned and owned touch point can lead to breakthrough results by delivering deep customer intelligence, micro-segmentation, and targeting opportunities.

Discover how leading marketers successfully transform customer data to:

• Better understand and engage the new digital buyer across the evolving customer journey
• Improve relevance and campaign performance
• Enhance cross-channel marketing program effectiveness

Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how South Korea interacts with and utilizes ICH standards and how they relate with other national regulatory agencies.

The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution. This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within South Korea and how best to consider the country into one's Business Strategy.

Agenda of the Session:
Overview of South Korea's Healthcare System
South Korea’s Regulatory Agencies Structure and Responsibilities
South Korean Drug Development Process
Agency Review Process for Decision-Making
Country Establishment Licensing & Procedures
South Korea and ICH (International Conference on Harmonization)
Requirements for Clinical Trials in South Korea
The Changing KFDA
Product Labeling Requirements
Cultural Aspects - Working in South Korea
Effectively working with the Regulators; Do's and Don'ts, Practical Experiences Shared
Learning Objectives: This course is designed to provide an overview of the regulatory environment in South Korea and will provide training in:
What is the Regulatory Structure in South Korea
Understanding the specific procedures for Pharmaceutical Products
How to begin your company involvement in South Korea
Requirements for Clinical Trials in South Korea
South Korean Drug Development Process
The Changing KFDA
Understanding the Local Culture: How to negotiate with the regulators

Who will benefit: This course will be of benefit to regulatory personnel whose responsibilities require knowledge of South Korea's regulatory environment. Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant. Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.

For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Overview: CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

A compliant CAPA system is required to to "close-the-loop" complaints, non-conformances, out-of specification conditions, and must include proper impact analysis / actions. As such CAPA is a major element of cGMP compliance (one of the four key inputs of QSIT, the FDA's Quality Systems Inspection Technique), and is also a key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? Use the CAPA system not just to satisfy regulatory requirements, but to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize costly product quality problems.

Why should you attend: Expectations for meaningful, results driven CAPA (Corrective and Preventive Action) System that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, with good reason. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system utilizes root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective, "closed loop" CAPA is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA, an integral part of viable Quality Management / cGMP planning, implementation and execution systems.

Areas Covered in the Session:
Regulatory "Hot Buttons"
CAPA Background
Correction, Corrective Action, Preventive Action Defined
Impact Analysis and Response - a Key Component
CAPA System Assessment
"Bullet-Proof"
Data Sources / Metrics
Monitor for Effectiveness
"Closed-Loop" - Lock In the Change
Beyond Regulatory Compliance

Who Will Benefit:
Senior Management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Overview: Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.

The reports further indicated that many issues have to be addressed prior to successful implementation of UDI for devices, including determining the technology needed to utilize UDI effectively, identifying the data needed for patient safety; development, maintenance, and validation of a central data repository; and harmonizing UDIs for the international marketplace. FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely into two categories: labeling and tracking. How does UDI fall into this category?

Why should you attend:
Understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting. Understand some of the issues associated with the use of various automatic identification technologies (e.g., bar code, radiofrequency identification). On February 26, 2004, FDA published a final rule (the ``bar code rule'') (69 FR 9120 ) requiring bar codes on certain human drug and biological products to help reduce medication errors in hospitals and other health care settings. The bar code is intended to enable health care professionals to use bar code scanning equipment in conjunction with computerized medication administration systems to verify that the right drug, in the right dose, is being given to the right patient at the right time. This rule (now codified at 21 CFR 201.25 and 610.67) requires that manufacturers encode the unique National Drug Code (NDC) number in a linear bar code on the product's label. The bar code rule, however, does not apply to medical devices. In the bar code rule, FDA stated that, unlike drugs, medical devices do not have a standardized, unique identifying system comparable to the NDC number, and that the absence of such a system complicates efforts to put bar codes on medical devices for purposes of preventing medical errors. Since the issuance of the final bar code rule, various entities, including members of Congress and a consortium of hospital groups and manufacturers, have asked that the Agency revisit the issue of bar coding medical devices to improve patient safety; improve quality of care; and encourage cost effectiveness, e.g., of health care by improving delivery and supply chain efficiency.

Areas Covered in the Session:
Understand how to implement the Unique Device Identification
Identify the uses and benefits of UDIs
Understand the challenges, recommendations and proposed conclusions from multiple groups
Review examples of Device Identification management scenarios reflecting the benefits
Learn where the use of medical device identification encompasses four current main elements

Who Will Benefit: This webinar will provide a general overview and update to companies who need to better understand industry's and FDA's current overview of Unique Device Identification. The employees who will benefit include:
All end-users from appropriate departments who desire or require a better understanding and overview of Unique Device Identification and current update.
QA and Compliance
Regulatory Affairs and RA Specialists
Marketing
Consultants

Technical Writers and employees who review labeling/tracking info
David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Overview: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

Why you should attend: What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance.

Areas Covered in the Session:
How to prepare for an FDA inspection?
Development and contents of an SOP for FDA inspection.
Reliance of FDA inspectors on compliance program guide manuals.
Reliance of FDA inspectors on other external sources.
Personnel training before inspection.
In depth review and summary of QSIT.
Use of QSIT for internal auditing.

Who Will Benefit: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Executive/Senior Management
Regulatory Management
QA Management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality System Auditors

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Overview: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

Why you should attend: What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance.

Areas Covered in the Session:
How to prepare for an FDA inspection?
Development and contents of an SOP for FDA inspection.
Reliance of FDA inspectors on compliance program guide manuals.
Reliance of FDA inspectors on other external sources.
Personnel training before inspection.
In depth review and summary of QSIT.
Use of QSIT for internal auditing.

Who Will Benefit: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Executive/Senior Management
Regulatory Management
QA Management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality System Auditors

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Overview: Analyzing biological fluids is one on the most difficult tasks in analytical laboratories. Most challenging are interferences from matrices and decomposition products combined with low concentrations of analyte. Correct validation of bioanalytical methods according to recent FDA and industry recommendations ensures reliability, consistency and accuracy of bioanalytical data. But because of the difficult nature of the analysis there are many questions. This seminar will demonstrate how to validate bioanalytical methods and procedures for FDA compliance.

Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.

Reference material for easy implementation:
Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
Gap Analysis/Checklist: Good Laboratory Practice Regulations
SOP: Archiving GLP Data and Other Documents

Areas Covered in the Session:
FDA and International GLP regulations: 21 CFR Part 58, OECD
Objectives and concepts of GLP's
Special organizational requirements
Responsibilities: Management, Study director, QA, analysts
SOP requirements: type, formats and enforcement
GLP studies: preparation, conduct, documentation
Key requirements for equipment, facilities reference material, people
Data generation and evaluation: raw data, intermediate results, final results
Records keeping: format, length of time, archiving and reprocessing
Preparing for FDA inspections

Who Will Benefit:
Laboratory managers and supervisors
GLP auditors
GLP study directors
QA/QC managers and personnel
Analysts and other laboratory staff
Regulatory affairs
Training departments
Consultants

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801