CalFeed is a place to Share and Discover Online Events. This feed contains the latest Front Page Events. http://calfeed.com A Refreshingly Different Approach to Ensuring Product Quality, Brand Reputation and OPEX in Food and Beverage: While F&B companies face numerous challenges: from tightening regulations to supplier quality issues and shrinking operating margins - there's one factor that connects them all: quality management. http://calfeed.com/events/2265-Ensuring-Product-Quality-Brand-Reputation-and-OPEX-in-Food-and-Beverage http://calfeed.com/2265 Fri, 10 May 2013 19:07:19 +0000 In this webinar, David J. Wudyka will describe a series of statistical concepts used by Compensation practitioners. The concepts to be covered include ideas such as pay structure development; "control points" in pay ranges, including minimums etc.. http://calfeed.com/events/2244-Basic-Compensation-Statistics----Webinar-by-TrainHR http://calfeed.com/2244 Mon, 06 May 2013 05:57:30 +0000 Please join us for an eGestalt educational webinar on HIPAA Omnibus Demystified – Implications for healthcare providers and business associates presented by Anupam Sahai on May 22, 2013 & May 29, 2013. http://calfeed.com/events/2297-Webinar-on-HIPAA-Omnibus-Demystified http://calfeed.com/2297 Mon, 20 May 2013 08:21:34 +0000 Are you working way too hard to getting the clients you want? Discover how you can overcome the 3 biggest roadblocks to more clients with marketing strategies that actually get the job done! Why not end the struggle and start thriving! Claim your spot on our webinar today! http://calfeed.com/events/2257-3-Marketing-Success-Strategies---How-To-Break-Through-The-Roadblocks-To-Getting-More-Clients! http://calfeed.com/2257 Thu, 09 May 2013 19:16:31 +0000 The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness.

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/168Bsu5 http://calfeed.com/events/2269-Device-Changes-FDA-Changes-and-the-510(k)---Webinar-By-GlobalCompliancePanel http://calfeed.com/2269 Tue, 14 May 2013 05:12:47 +0000 Mobile medical applications and devices is a growing field globally. New rules and regulatory efforts are coming to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.


Speaker : Kosta Makrodimitris
Product ID : F62320
Schedule Date :
Thursday, May 23, 2013
duration : 01:00 to 02:30 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=59&productKey=238 http://calfeed.com/events/2263-Mobile-Medical-Applications-and-Devices:-Trends-and-Regulations-in-US-&-Globally http://calfeed.com/2263 Fri, 10 May 2013 11:52:02 +0000 This program is designed for regulatory professionals and others interested in understanding the basics of the regulation of pharmaceutical and biologic products in Canada.


Speaker : Dr. Linda Yang
Product ID : F62404
Schedule Date :
Thursday, May 23, 2013
duration : 11:00 to 12:00 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=36&productKey=253 http://calfeed.com/events/2264-Canada-pharmaceutical-registration-and-regulations http://calfeed.com/2264 Fri, 10 May 2013 11:53:36 +0000 Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work. This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes.

Location: Orange County CA | May 23rd & 24th, 2013
Conference Timings: 9 am to 6 pm PST

Price – $1,295.00

Contact Information:
GlobalCompliancePanel
Event Coordinator
Toll free: 800-425-9409
Fax: 302-288-6884
http://www.globalcompliancepanel.com
Email: support@globalcompliancepanel.com http://calfeed.com/events/2064-2-day-In-person-Seminar-on-“Design-of-Experiments-and-Statistical-Process-Control-for-Process-Development-and-Validation”-at-Philadelphia-PA http://calfeed.com/2064 Wed, 12 Dec 2012 06:29:24 +0000 This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process for better optimization.

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/YSlNfu http://calfeed.com/events/2270-Key-Concepts-in-Successful-Water-System-Sanitization----Webinar-By-GlobalCompliancePanel http://calfeed.com/2270 Tue, 14 May 2013 05:14:35 +0000 This webinar is intended to demonstrate how to prepare a 510(k), submit, and get it cleared in a manner with increased quality so that the review process can be expedited.

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/10UeePJ http://calfeed.com/events/2271-FDA-510(k):-Preparation-Submission-and-Clearance----Webinar-By-GlobalCompliancePanel http://calfeed.com/2271 Tue, 14 May 2013 05:16:30 +0000 This medical device risk analysis training will explain the relationship between ISO 14971 compliance and the EU MDD. It will discuss how you can update your risk management procedure to meet CE mark requirements for risk analysis. http://calfeed.com/events/2274-ISO-14971:2012---Does-your-current-Risk-Analysis-still-comply-with-your-CE-Mark-requirements? http://calfeed.com/2274 Tue, 14 May 2013 12:50:36 +0000 Managing tax and statutory compliance in an era of rapid globalization, new developments in tax laws, and continuous changes in accounting standards across the globe, is a challenge to corporates. Take a look at the focal issues of taxation and compliance in this one hour interactive seminar presented by Nair & Co. and FEI.

Agenda Covers:

• An overview of International Tax Regimes, which will cover favourable and unfavourable global tax structures, regulations, incentives and penalties.
• Learn about foreign tax credits.
• What are the key compliance and planning issues for international trade and customs issues?
• What are the key global taxation strategies for corporates to balance risk and opportunity?
• Why outsourcing compliance is an Attractive option?

Date: May 23, 2013
Time: 11:00 am PST / 2:00 pm EST

Presenters-
Dr. Shan Nair, Co-founder, Nair & Co.
Venkatesh Eswaran, Senior Vice President, Global Services, Nair & Co.
Frank Girolamo, Vice President, Finance, Ipswitch

About Nair & Co.
Nair & Co. provides you with your one touch outsourced finance, internal audit compliance, HR and legal department for your international operations. If you are expanding abroad for the first time, our turnkey solution will help you do so with minimal risk, stress and cost. We currently support more than 1000+ client operations in over 50 countries and have core offices in U.K., India, China, U.S., Japan and Singapore. Nair & Co. was named among the top 100 outsourcing services providers in the world by the International Association of Outsourcing Professionals (IAOP). Learn more at www.nair-co.com http://calfeed.com/events/2309-Webinar--Global-Taxation-and-Compliance-Issues http://calfeed.com/2309 Wed, 22 May 2013 04:28:39 +0000 Come and meet SecPoint at Internet Discovery Day in Malmo 2013 http://calfeed.com/events/2305-SecPoint-at-Internet-Discovery-Day-Malmo http://calfeed.com/2305 Mon, 20 May 2013 11:18:08 +0000 This session will explain how a hospital medical staff should deal with the practitioner who is disruptive of hospital operations. It will discuss disruptive practitioner policies a hospital should have in place and practical tips to correct or terminate the disruptive activity. http://calfeed.com/events/2277-Dealing-with-the-Disruptive-Practitioner-in-a-Legally-Compliant-Manner http://calfeed.com/2277 Wed, 15 May 2013 07:21:17 +0000 Love dance? Hate admin!

Attend the DanceBiz free webinar and find out how to minimise your dance school administration.

Are you spending hours on your administration?
Our easy-to-use software will change your dance business forever!

Save valuable time and manage your dance school's:

• Customer database & records
• Online class timetables
• Term registers
• Bulk email & texting to customers
• Invoicing

Smartphone & tablet app available!

DanceBiz's Free Webinar 28th May, 11:00am - 11:40am

All attendees will receive a free 30-day trial. http://calfeed.com/events/2308-DanceBiz:-Love-Dance?-Hate-Admin!-Webinar http://calfeed.com/2308 Tue, 21 May 2013 14:33:03 +0000 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)


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. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management. http://calfeed.com/events/2298-Device-Corrections-and-Removals----Webinar-By-GlobalCompliancePanel http://calfeed.com/2298 Mon, 20 May 2013 09:07:47 +0000 Join us for a 60 minute webinar where we bring on Donya Rose, Managing Principal of The Cygnal Group, located in Chapel Hill, North Carolina, will discuss how a sales comp designer holds the line and keep the plans simple and motivating. http://calfeed.com/events/2204-Simple-vs.-Fair:-Minimizing-Measures-to-Maximize-Results-in-Your-Sales-Comp-Plans---Webinar-by-TrainHR http://calfeed.com/2204 Tue, 16 Apr 2013 04:39:07 +0000 The webinar will cover a host of issues concerning when employers' rights in investigating their employees' conduct conflicts their employees' right to privacy. Can you search your employee's desk or locker? Can you search your employee's briefcase/purse? Can you search emails or monitor voice mails? http://calfeed.com/events/2228-When-Employee-Privacy-Trumps-Employer-Rights---Webinar-by-TrainHR http://calfeed.com/2228 Tue, 30 Apr 2013 04:48:07 +0000 This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.


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/U1VDxM http://calfeed.com/events/2272-Global-Medical-Device-Adverse-Event-Reporting-Systems-in-EU-Canada-and-US---Webinar-By-GlobalCompliancePanel http://calfeed.com/2272 Tue, 14 May 2013 05:18:26 +0000 This training on disinfectant qualification studies will discuss the many methods and variations used for disinfectant qualifications, the pitfalls in each method, the errors that can occur and how to identify them. It will show how you can translate the disinfectant qualification results to effective cleaning procedures and avoid FDA observations. http://calfeed.com/events/2276-Understanding-Disinfectant-Qualification-Studies---How-To-Avoid-Errors http://calfeed.com/2276 Wed, 15 May 2013 07:20:06 +0000 This medical device risk management webinar will discuss how to develop a Risk Management File in compliance with FDA and ISO 14971 requirements and what FDA will look for in risk evaluation and mitigation strategies (REMS) prior to or post approval of medical devices. http://calfeed.com/events/2289-Developing-a-Post-Approval-Risk-Management-Strategy-for-Medical-Devices http://calfeed.com/2289 Thu, 16 May 2013 11:18:39 +0000 This training on construction fraud prevention will discuss proven audits strategies and techniques for detecting and preventing common fraud and risk in construction activities. Attendees will also learn how to manage when fraud arises and the tips to effectively control construction costs. http://calfeed.com/events/2291-Construction-Fraud---Ways-to-Identify-them-and-Prevent-them http://calfeed.com/2291 Thu, 16 May 2013 12:17:00 +0000 Get the information you need to make good decisions when adding mobile support to your software or SaaS system using case study examples from software companies that have mobilized their products. http://calfeed.com/events/2249-Building-Mobile-Apps-for-Software-Products http://calfeed.com/2249 Tue, 07 May 2013 19:34:30 +0000 This session is designed to help you manage more effectively by understanding the reasons for conflicts and giving you ways to diffuse negative employees to get desired results and increased productivity and teamwork. http://calfeed.com/events/2273-Conflict-Management-and-Dealing-with-Difficult-People http://calfeed.com/2273 Tue, 14 May 2013 10:16:27 +0000 This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA. http://calfeed.com/events/2290-FDA-Warning-Letter-Closeout-Program http://calfeed.com/2290 Thu, 16 May 2013 12:05:33 +0000 This webinar will provide advanced training in planning, executing, and reporting HR audits. Critical HR audit issues will be review including developing an HR audit plan, identifying audit stakeholders, critical employment practice areas, and analyzing key performance and risk indicators. http://calfeed.com/events/2294-Advance-HR-Audit-Techniques http://calfeed.com/2294 Fri, 17 May 2013 10:57:04 +0000 An electronic health record (EHR) allows providers to record patient information electronically instead of using paper records. The EHR Incentive Program asks providers to use the capabilities of the EHRs to improve patient care.

The Medicare EHR Incentive Program provides incentive payments to eligible professionals, eligible hospitals, that demonstrate meaningful use of certified EHR technology. The Medicare EHR Incentive Program for eligible professionals started in 2011, and EHR incentive payments under Medicare will continue through 2016.

Similarly the Medicaid EHR Incentive Program provides incentive payments to eligible professional and hospitals across the US states. The Medicaid EHR Incentive Program is offered and administered voluntarily by states and territories. There are currently 47 states that offer the EHR Incentive Programs. The last year that an eligible professional can begin participation in the Medicaid EHR Incentive Program is 2016.

Why Should You Attend:This webinar will provide the new and expected stages and policies for Medicaid/Medicaid EHR Incentives and discuss their effects across the states and the industry. We will explain what the policies are, predict coming regulations and discuss how industry (Vendors) will be affected. We will explore relevant regulations and standards in US and globally.

The Medicare EHR Incentive Program for eligible professionals started in 2011, and EHR incentive payments under Medicare will continue through 2016. All groups and professionals who have responsibility or need to understand the basics of Medicaid/Medicaid EHR Incentives should attend.

Who Will Benefit:
Medical doctors and professionals
Nurses
Management
Health IT Managers
Research and Development
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). He is involved as, Medical Devices Committee Member, Writer at The Food and Drug Law Institute, Consultant (Health Informatics/Policies/Standards) at DHHS/ONC, Standards & Interoperability Health Information Management Systems Society, Health Level 7(EHR, Genomics, mHealth) , small businesses, Nifty-Fifty Nominee nationwide, Speaker, Volunteer at USA Science Festival http://calfeed.com/events/2299-Medicaid-Vs.-Medicaid-EHR-Incentives-&-Meaningful-Use-Certifications-in-US---Webinar-By-GlobalCompliancePanel http://calfeed.com/2299 Mon, 20 May 2013 09:14:20 +0000 While some critics charge that FDA’s oversight of dietary supplements is lax, creating an almost “Wild West” flavor to the industry, the reality is that the FDA has significant authority to enforce an array of legal and regulatory requirements on the dietary supplement industry. These requirements range from review of new dietary ingredients (NDI) to health claims and structure/function claims for dietary supplements, to the agency’s increased sophistication in enforcing the 2007 Good Manufacturing Practice (GMP) requirements applicable to dietary supplement operations. http://calfeed.com/events/2193-Live-Webinar-on-Key-Issues-in-FDA-&-FTC-Regulation-of-Dietary-Supplements-By-Compliance2go http://calfeed.com/2193 Fri, 12 Apr 2013 11:40:54 +0000 Ron Crabtree, thought leader and CEO of MetaOps, Inc will present a live eSeminar. This event features his legendary “How Your Call Center Is Like Your Canary In Your Coal Mine.” You’ll identify how to leverage information gathered from your call center to mine for gold throughout your organization. Free to attend, and open for questions. http://calfeed.com/events/2296-How-Your-Call-Center-Is-Like-Your-Canary-In-A-Coal-Mine http://calfeed.com/2296 Fri, 17 May 2013 15:21:29 +0000 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. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO. http://calfeed.com/events/2301-Importing-and-Exporting-Medical-Devices:-A-Primer-on-Regulatory-Strategy-and-Requirements---Webinar-By-GlobalCompliancePanel http://calfeed.com/2301 Mon, 20 May 2013 09:21:22 +0000 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.

Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. http://calfeed.com/events/2302-The-Hitchhiker's-guide-to-483s-and-Warning-Letters---Webinar-By-GlobalCompliancePanel http://calfeed.com/2302 Mon, 20 May 2013 09:25:26 +0000 This webinar on Procure to Pay (P2P) process will highlight the evolution of the P2P function from a manual to an automated process. It will clearly explain the ways to implement a P2P automation solution and its contribution to the financial and operational success of an organization. http://calfeed.com/events/2304-Procure-to-Pay-(P2P)-Systems-and-Automation-Solutions http://calfeed.com/2304 Mon, 20 May 2013 09:49:31 +0000 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. http://calfeed.com/events/2307-Assay-Validation-for-Clinical-Diagnostics http://calfeed.com/2307 Tue, 21 May 2013 09:38:54 +0000 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.

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). He is involved as, Medical Devices Committee Member, Writer at The Food and Drug Law Institute, Consultant (Health Informatics/Policies/Standards) at DHHS/ONC, Standards & Interoperability Health Information Management Systems Society, Health Level 7(EHR, Genomics, mHealth) , small businesses, Nifty-Fifty Nominee nationwide, Speaker, Volunteer at USA Science Festival http://calfeed.com/events/2300-e-Submissions-&-Data-Standards-for-FDA-(eCTD-CDISC-HL7)---Webinar-By-GlobalCompliancePanel http://calfeed.com/2300 Mon, 20 May 2013 09:17:32 +0000 This clinical trial audit training will explain how to identify gaps and risks when preparing for regulatory inspections of sponsor monitoring programs by understanding the components of a clinical trial quality monitoring system. http://calfeed.com/events/2292-Clinical-Trials-Audit-Proof-Monitoring-Programs http://calfeed.com/2292 Fri, 17 May 2013 10:32:38 +0000 This webinar will provide an in-depth understanding of anti-kick back and stark laws, and discuss how marketing activities can trigger either or both. It will show how to implement mandatory internal controls to reduce exposure to risks. http://calfeed.com/events/2293-Anti-Kickback-Stark-Laws-and-Marketing http://calfeed.com/2293 Fri, 17 May 2013 10:37:31 +0000 This training on harassment investigations in the workplace will cover practical steps to conduct effective and legally compliant investigations into harassment, discrimination, or other misconduct allegations/ complaints. http://calfeed.com/events/2303-The-Psychology-(and-Law)-of-Harassment-Investigations http://calfeed.com/2303 Mon, 20 May 2013 09:44:49 +0000 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. http://calfeed.com/events/2306-FDA's-Regulation-of-Cosmetic-Labeling-Under-the-Federal-Food-Drug-and-Cosmetic-Act http://calfeed.com/2306 Tue, 21 May 2013 09:33:46 +0000 This training will teach you how to prepare for a medical staff professional review adverse action hearing, including what steps are necessary to afford the respondent practitioner due process. http://calfeed.com/events/2311-(Medical-Staff)-Fair-Hearings-From-a-Hearing-Officer's-Perspective---Is-Your-Process-Lawsuit-proof? http://calfeed.com/2311 Wed, 22 May 2013 06:58:12 +0000 This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product. http://calfeed.com/events/2312-Remediating-Pharmaceutical-Water-System-Biofilm---What-to-Do-After-It-Gets-Ahead-of-You http://calfeed.com/2312 Wed, 22 May 2013 07:06:12 +0000 Torn from the front pages of today’s newspapers, serious product quality problems, only discovered after spiraling into a public crises, have plagued FDA regulated industries in recent years. Are you prepared to quickly and appropriately respond to a detected serious product quality problem and prevent it from quickly escalating into a public relations nightmare? http://calfeed.com/events/2194-Live-Web-Seminar-on--Serious-Product-Quality-Problems-–-Dealing-with-the-Press-and-the-Public-By-Compliance2go http://calfeed.com/2194 Fri, 12 Apr 2013 11:42:34 +0000 Participants who are new to Executive Compensation will benefit by this overview of the Executive Compensation Program in companies of all types. http://calfeed.com/events/2278-90-Minutes-Webinar-on-Executive-Compensation http://calfeed.com/2278 Wed, 15 May 2013 11:14:09 +0000 This webinar will cover in detail how to produce high quality documentation. This webinar will also teach you what not to do in terms of documentary practices including in regards to timing, content and purpose. This webinar will include examples of documentation both good and poor.
This webinar will also cover how to persuade your managers to view documentation as important for them as it is to the company. http://calfeed.com/events/2279-How-To-Produce-High-Quality-Defensible-Employment-Documentation http://calfeed.com/2279 Wed, 15 May 2013 11:15:45 +0000 Participants who are new to Executive Compensation will benefit by this overview of the Executive Compensation Program in companies of all types. It will help those who have to design a new program for the first time, as well as those who need insight into established program concepts. http://calfeed.com/events/2284-90-Minutes-Webinar-on-Executive-Compensation http://calfeed.com/2284 Thu, 16 May 2013 06:34:51 +0000 This webinar will cover in detail how to produce high quality documentation. This webinar will also teach you what not to do in terms of documentary practices including in regards to timing, content and purpose. This webinar will include examples of documentation both good and poor. http://calfeed.com/events/2285-How-To-Produce-High-Quality-Defensible-Employment-Documentation http://calfeed.com/2285 Thu, 16 May 2013 06:40:32 +0000 This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits. http://calfeed.com/events/2310-Meet-the-Tougher-U.S.-FDA-CGMPs http://calfeed.com/2310 Wed, 22 May 2013 06:54:22 +0000 The lecture covers the topic of perception and reality. To be able to show science in risk assessment it has been necessary to design experiments to gather data to allow occurrence to be set in a risk assessment. This use of data has revealed some very interesting anomalies which are discussed. http://calfeed.com/events/2195-Shared-facilities-and-the-move-to-science-based-risk-assessments-By-Compliance2go http://calfeed.com/2195 Fri, 12 Apr 2013 11:44:26 +0000 This webinar will explain what protected concerted activity means and will cover areas such as your social media policy and your policy on revealing wage information. http://calfeed.com/events/2280-The-National-Labor-Relations-Act--Not-Just-for-Union-Companies http://calfeed.com/2280 Wed, 15 May 2013 11:17:50 +0000 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. http://calfeed.com/events/2281-National-Labor-Relations-Act:-Employee-Rights-and-Pitfalls http://calfeed.com/2281 Wed, 15 May 2013 11:20:09 +0000 Union membership is at an all-time low. As a result many companies think the National Labor Relations Act is unimportant to most companies. Unfortunately nothing could be further from the truth. The current National Labor Relations Board is very active in dealing with situations that deal with union and non-union company actions. http://calfeed.com/events/2286-The-National-Labor-Relations-Act--Not-Just-for-Union-Companies http://calfeed.com/2286 Thu, 16 May 2013 06:42:00 +0000 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. http://calfeed.com/events/2287-National-Labor-Relations-Act:-Employee-Rights-and-Pitfalls http://calfeed.com/2287 Thu, 16 May 2013 06:45:47 +0000 This course is designed to provide a microbiology-focused education about all aspects of water systems and how Biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understand this very important subject matter.

Price: $1,295.00

Contact Information:

GlobalCompliancePanel
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
Event Link - http://bit.ly/15BsuC2 http://calfeed.com/events/2235-2-day-In-person-Seminar-on-“Mastering-Biofilm-Control-Monitoring-Validation-and-Excursion-Investigations-of-Pharmaceutical-Water-Systems”-at-Anaheim http://calfeed.com/2235 Thu, 02 May 2013 09:52:53 +0000 The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and many organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations, and recent significant chganges to the rules. http://calfeed.com/events/2196-Live-Webinar-on--New-HIPAA-Breach-Notification-Standards---Tougher-Rules-Require-Risk-Assessment-By-Jim-Sheldon-Dean http://calfeed.com/2196 Fri, 12 Apr 2013 11:46:06 +0000 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? http://calfeed.com/events/2282-How-Much-is-Too-Much?-Predicting-and-Assessing-The-Cost-of-The-Sales-Team http://calfeed.com/2282 Wed, 15 May 2013 11:21:46 +0000 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? http://calfeed.com/events/2288-How-Much-is-Too-Much?-Predicting-and-Assessing-The-Cost-of-The-Sales-Team http://calfeed.com/2288 Thu, 16 May 2013 06:48:29 +0000 The pay gap between men and women currently stands at around 77% and it has been this way since the early 80s. Why has there been no progress since? President Obama believes it is because enforcement has not been aggressive enough. After all, this pay gap must mean pay discrimination is out there. http://calfeed.com/events/2283-How-and-Why-the-Feds-Are-Aggressively-Focuses-on-Employer-Pay-Practices http://calfeed.com/2283 Wed, 15 May 2013 11:23:10 +0000 Over the past decade, the FDA and the Department of Justice have aggressively prosecuted -- both criminally and civilly -- pharmaceutical firms for promoting their drugs for off-legal uses. In the process, the Federal Government has recouped billions of dollars from drug firms under the False Claims Act in connection with allegedly illegal off-labeled promotion. http://calfeed.com/events/2197-Live-Audio-Conference-on--The-Future-of-Off-Label-Marketing-After-the-Caronia-Decision-By-Compliance2go http://calfeed.com/2197 Fri, 12 Apr 2013 11:48:27 +0000 Top 4 Packers and Movers in Bangalore is an Online platform where you'll get best, affordable, trustworthy and reputed Packers and Movers in Bangalore in Just one click.

Top 4 Packers and Movers in Bangalore is the best Packers and Movers service provider in Bangalore region. Packers and Movers Bangalore rates are very competitive in the market. Packers and Movers Bangalore believe in best service in best rates. Packers and Movers Bangalore first priority job is customer satisfaction. Become a "Best Packers and Movers in Bangalore" is their vision & target is to achieve best in Packers And Movers Services. Packers and Movers Bangalore are giving more focus on customer centrality. http://calfeed.com/events/2242-Packers-and-Movers-in-Bangalore http://calfeed.com/2242 Sat, 04 May 2013 17:39:45 +0000 In this two-day seminar, you will learn how to configure your Excel application with the features required for 21 CFR Part 11 compliance, helping you to avoid 483s. Using the risk-based computer system validation approach, you will validate your own Excel application.

Price: $1,295.00

GlobalCompliancePanel

Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
Event Link - http://bit.ly/17J1Gkt http://calfeed.com/events/2248-2-day-In-person-Seminar-on-Validate-your-own-Excel-Spreadsheet-Application-at-Washington-DC http://calfeed.com/2248 Tue, 07 May 2013 09:48:50 +0000 • The course is highly interactive, using real life examples and proven techniques.
• You will learn how to use electronic records and electronic signatures to maximize productivity. http://calfeed.com/events/2176-2-day-In-person-Seminar-on-Software-Validation-for-the-New-FDA-Inspections-at-Hotel-Lalit-Mumbai http://calfeed.com/2176 Mon, 08 Apr 2013 13:01:09 +0000 CAPA systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry-FDA environment and will give you tools for survival; it will provide a step-by-step guide to the setting-up, operation, management and auditing of a CAPA system for today’s FDA regulated industry environment. http://calfeed.com/events/2198-Live-Web-Conference-on--CAPA-–-The-Heart-of-Your-Quality-System-By-Compliance2go http://calfeed.com/2198 Fri, 12 Apr 2013 11:49:58 +0000