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The objective of this 45-minute complimentary webinar is to inform you of key points and recent development of the Regulation and help you to understand the likely impact on your day-to-day activities.

Participants will also receive access to the complimentary copy of SGS’s new white paper "Understanding the EU Timber Regulation 995/2010 and its Implications" at the end of the webinar.

Agenda

• Introduction
• Effective Dates, History and background
• Articles in the regulation relating to Operators and Traders
• The role of chain of custody and third party verification schemes
• SGS Services to Operators and Traders

Background

European Union Regulation 995/2010 lays down the obligations for Operators who place timber and timber products on the European market for the first time, as well as the obligations of Traders in the supply chain between the forest of origin and the end user.

The Regulation prohibits the supply of illegally harvested timber in the European market. In addition, Operators must exercise due diligence when placing timber or timber products on the market. They shall use due diligence system to assess and mitigate the risk of illegal timber being supplied.

SGS has identified the obligations for organizations that fall within the scope of the Regulation. The webinar is designed to provide clarification on specific issues.

The webinar is designed to provide participants with an understanding of Articles within the Regulation. The webinar will also provide information about the services and solutions offered by SGS to facilitate compliance with the Regulation.

The webinar will be delivered by experts with experience auditing chain of custody systems and will presented in a relevant and informative manner by individuals with specific experience of the timber, paper and packaging sectors.

Target Audience

Organizations involved with the supply and trade of timber, paper and packaging products

Operators: Organizations or individuals responsible for placing timber on the European market.

Traders: Organizations or individuals that purchase and or sell timber products, but do not take responsibility for first placement on the market.

Presenter

Mr. Tobin Gordon, SGS Global Program Manager, Chain of Custody.

Tobin has twelve years experience auditing chain of custody systems and managing chain of custody programs. Tobin is currently working on a programme to deliver solutions to clients that facilitate compliance with European Union Regulation 995/2010. Tobin is also working to align delivery of chain of custody systems across the SGS network.

Join one of the following complimentary sessions on May 22, 2012:

Register for Session 1

09:00 a.m. London
10:00 a.m. Paris, Berlin, Madrid, Amsterdam
04:00 a.m. New York
04:00 p.m. Singapore, Kuala Lumpur

Register for Session 2

02:00 p.m. London
03:00 p.m. Paris, Berlin, Madrid, Amsterdam
09:00 a.m. New York
09:00 p.m. Singapore, Kuala Lumpur

Event location: Online

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Why Should You Attend:

The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The "Special" and "Abbreviated" 510(k)s must also address them, but in different ways. In addition, the FDA Task Force has identified several problem areas with the existing medical device 510(k) process, leading to the growing push by the Agency to strengthen the 510(k) process. What can companies do proactively to address these concerns and better ensure a smoother review process?

Areas Covered in the Seminar:

• The Three Types of 510(k)s and Their Uses.
• The 21 Required Elements in the 510(k), and How Documented.
• Finding, Proving and Documenting Substantial Equivalence.
• Addressing Product "With-" or "As-software" Issues.
• The "Statement" or The "Summary".
• Documenting "Hazards Analysis", and the MAUDE Database.
• The Declarations.
• U.S. FDA Device Clearance Process.

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations.

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702323?channel=webinarhero

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Why Should You Attend:

Due to the significant number of fatalities, injuries, fires, spills/releases, and "near misses" in manufacturing, OSHA requires procedures for isolating energy sources and equipment startup. Due to unauthorized persons trespassing or accidentally accessing the area and multiple employers working on these projects they are a significant target for lawsuits for accidental releases of energy or startups. Plaintiff attorneys target the failure of parties responsible for isolating energy sources and controls. Unfortunately, in most cases defendants were not aware of the OSHA requirements until it is too late. In 2011 lockout/tagout ranked 5th in the most common OSHA citation with 3,756 violations.

Areas Covered in the Seminar:

• To assess energy sources, both potential and kinetic.
• To isolate and assure all power utilities or any potential energy sources are isolated or discharged as in the cases of capacitors.
• Both manufacturing personnel construction contractors to take measures and develop work plans in preparation to deal with operating systems, live and stored energy.
• Energy sources may include in addition to electrical, pneumatic, hydraulic, chemical, thermal, mechanical, etc.

Who Will Benefit:

This webinar will provide valuable assistance to all construction and demolition companies/ manufacturing sites with renovations. Those that would benefit most would be:

• Manufacturers
• Construction contractors
• Engineering companies
• Safety Managers and Directors
• Supervisors
• Safety Consultants

Jon J. Pina, has spent over 13 years with the PA/OSHA Consultation Program. Jon holds a BS in Geoscience Education, MS in Geology, and MS in Safety Management, all from Indiana University of Pennsylvania, and has been a Certified Safety Professional since 1994. In addition to being a safety professional, Jon has worn many "hats" and has extensive industrial experience as a chemical plant operator, pipefitter, construction manager of large industrial construction and demolition projects, and corporate safety director.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702326?channel=webinarhero

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Why Should You Attend:

Failure modes and effects analysis (FMEA) can be a helpful tool in risk management for medical devices, but it has several inherent traps that should be recognized and avoided. The standard has been recognized by FDA, and in Europe through ISO 14971. Therefore compliance to this standard is crucial not only in assuring the safety and reliability of medical equipment, but in meeting regulatory requirements as well.

Areas Covered in the Seminar:

• FMEA methodology-the right way for efficiency.
• Design FMEA Procedure.
• How to save over 50% time for conducting FMEA.
• Process FMECA Procedure.
• How to eliminate defects in manufacturing.
• How to design validation tests from FMEA.
• How to reduce costs from using FMEA.

• Design engineers and managers
• Manufacturing engineers and managers
• Maintenance engineers and managers
• Risk Managers
• Compliance Officers
• Ethics
• Legal Professionals
• Senior Management

Instructor Profile:

Dev Raheja, a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and system reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and customer satisfaction.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702321?channel=webinarhero

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Why Should You Attend:

The last two years have seen major initiatives at the FDA; as well as prominent drug and device failures over cGMP issues, resulting in recalls, lawsuits, class action lawsuits, and even possible criminal prosecution. The FDA sees globalization as a growing reality, and potential contributor of major regulatory issues: the supply chain, counterfeiting, clinical trials, other global outsourcing actions; by global / multinational corporations. A new paradigm for FDA guidance and strengthened enforcement is called for.

Areas Covered in the Seminar:

• The U.S. FDA's New Global Engagement Initiatives.
• Recent global industry trends, bad and good.
• Major foreseeable problem areas.
• How the FDA initiatives impact regulated industries.
• Immediate actions to take.
• Long-term correction / preventive action of FDA-defined problem areas.

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations.

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702324?channel=webinarhero

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Why Should You Attend:

• Is an employer checking social media pages of employees, such as LinkedIn or Facebook an invasion of privacy?
• If an employee tells you about a post that another employee posted that is negative about your organization, what should you do?
• WHat social media information can be used in lawful hiring or termination of employees?
• What are the legal precedents we can use to help us figure out what to do?
• Can Social Media sites such as LinkedIn and Facebook give employers insight into a prospective employee's work ethic or frame of mind?

Areas Covered in the Seminar:

• Need to keep employee selection techniques job-related (federal requirement, with long case history that affirms this necessity.
• Can it be verified that applicants are 100% responsible for everything on their Facebook page?
• What might prospective employers hope to accomplish by reviewing an applicant's Facebook postings?
• Does reviewing an applicant's Facebook postings yield the information that a prospective employer can use to make a more informed hiring choice?

Who will benefit:

This webinar will provide valuable assistance to:

• Hiring Managers in private, public, and not-for-profit organizations
• Human Resource staff and managers in private, public, and not-for-profit organizations
• Supervisors in private, public, and not-for-profit organizations
• Chief Operating Officers, Chief Financial Officers, and others serving those roles in private, public, and not-for-profit organizations

Joe Gross, is a self-employed consultant with HR & Policy Solutions, PLLC in Olympia Washington. His consulting company develops a variety of human resource and policy systems for employers in the private, not-for-profit, and public sectors. Areas of emphasis in his practice are legal compliance, hiring, classification, writing employee manuals, and workforce alignment.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702330?channel=webinarhero

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Why Should You Attend:

Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls.

Areas Covered in the Seminar:

• FDA Quality System Requirements for software.
• FDA guidelines on Software Verification and Validation.
• Smart software verification methods.
• How to design smart validation tests.
• How to conduct Black box testing and white box testing to perform thorough validation.
• How to conduct diabolic tests and wicked tests to avoid product recalls.

• Software developers and managers
• Internal auditors
• Quality Assurance personnel and management
• Software Quality personnel
• Software Test personnel
• Business managers responsible for system compliance

Instructor Profile:

Dev Raheja, a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and system reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and customer satisfaction.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702320?channel=webinarhero

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Why Should You Attend:

The FDA's Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. Device firms are also subject to compliance to the FDA regulations of device recalls, reports of corrections and removals. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR, recalls, corrections and removals.

Areas Covered in the Seminar:

• Relevant Statutes And FDA Regulations.
• Definitions.
• Regulatory Requirements For Medical Device Reporting (MDR).
• How To Report A Medical Device Problem (MDR).
• Reporting Requirements For The User Facilities, Manufacturers, And Importers.
• Regulatory Requirements for Recall, Reports of Corrections And Removals.

The employees who will benefit include:

• Complaint handling personnel.
• Regulatory affairs (associates, specialists, managers, and directors).
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs).
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs).
• Research and development (associates, scientists, managers, directors and VPs).
• Product and development (associates, scientists, managers, directors and VPs).
• Marketing (associates, specialists, managers, directors and VPs).
• Site managers, and consultants.

Instructor Profile:

Dr. David Lim, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia in 1993. Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo and US FDA (Center for Devices and Radiological Health (CDRH) at US Food and Drug Administration)

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702318?channel=webinarhero

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Why Should You Attend:

This workshop will teach you the protocol for engagement on each social network, namely, Facebook, Twitter, Google+, and Pinterest. At the end of this workshop you will be able to develop guidelines for employee usage, and learn how to leverage social networks to increase your visibility among top candidates. You will also learn how to establish your company as an employer of choice. In addition, you will learn how to engage, and be successful on social networks. It all begins with a strong, and efficacious social media policy.

Areas Covered in the Seminar:

• What is a social media policy?
• Your rights as an employer to establish a social media policy and guidelines.
• What to include in your social media policy.
• Define the guidelines of each social network, its culture, and success factors, and best practices.
• Professionalism: how to interact, engage vs broadcasting automated messages.
• Morale and respect among coworkers, and managing expectations.
• Creative ways to engage employees to use social media.

• Human Resource Professionals
• First line Supervisors and Management
• Recruiters and Employment Specialists
• Training and Learning Professionals
• Compliance Officers
• Consultants and Business Owners

Margo Rose, M.Ed.,HRD is a mission-driven leader who transforms social media communities into passionate social media movements. Award winning social media manager, and blogger. More than 5+ years in depth experience across social media platforms. Awarded and ranked among The Top 25 Digital Media, HR, and Recruiting Influencers in The US (3 HR Examiner Lists 2011-20112). Interpreted social media metrics to direct the on-going strategy for corporate communication, marketing, and human resources for employer branding, and rapid response execution. Builds brand ambassador strategy and incentive programs that influence purchasing decisions.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702319?channel=webinarhero

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Why Should You Attend:

Most HIPAA covered entities now face difficult choices as mobile devices such as smart phones and tablets proliferate and become the standard for personal communications both by providers and their patients, and social networking sites become a preferred means of communication for many. Have you updated your information security risk analysis or policies and procedures to address the increasing use of mobile devices and social networking for patient communications? If not, you run the risk of breaches, rule violations, and fines in the event of mishandling of PHI using these new technologies.

Areas Covered in the Seminar:

HIPAA Compliance and New Technologies

• What HIPAA requires for Privacy
• What HIPAA requires for Security
• HIPAA Breach Notification requirements
• HIPAA audits and enforcement

• Objectives for Patient Care using portable devices
• Problems that can result
• Taking proper precautions with Portable Devices

Who Will Benefit:

• Information Security Officers
• Risk Managers
• Compliance Officers
• Privacy Officer
• Health Information Managers
• Information Technology Managers
• Medical Office Managers
• Chief Financial Officers

Instructor Profile:

Jim Sheldon-Dean, is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a variety of health care providers, businesses, universities, small and large hospitals, urban and rural mental health and social service agencies, health insurance plans, and health care business associates

For Registration :

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702335?channel=webinarhero

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