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Events for March 21, 2014

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----- Creating a Global Regulatory Plan
By COCOM 21 Mar 2014 - IFSQN.

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Event Organizer ComplianceOnline
Contact Name Referral
Contact Number +1-650-620-3915
Contact Email referral@complianceonline.com
Event Category Conference
Event State/City California
Event Country USA
Cost of Attendance $199.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703283?channel=IFSQN

Event Description


This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

Why Should You Attend:
How many of us have jumped into pursuing a new market before knowing the regulatory requirements and impact? If you have, you are not alone. Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.
This webinar will discuss generating and maintaining a global regulatory plan. Having and maintaining a strong global regulatory plan can help your business not only stay in compliance but can be an integral part of corporate marketing strategies.

Areas Covered in the Webinar:
  • Describe the primary benefits of developing and maintaining an effective Global Regulatory Plan.
  • Applicable Laws, Regulations, Guidance, Rules, and Standards in EU, Canada, and US.
  • Elements of an effective Global Regulatory Plan.
  • Interfacing: Roles and Benefits
  • Alignment between Regulatory Plan/Strategy, Reimbursement, and IP
  • Questions and Issues to Identify and Address
Who Will Benefit:

This webinar will provide valuable assistance to following personnel:
  • Regulatory managers
  • Project managers
  • Product development managers
  • Marketing managers
  • Staff involved with regulatory filings
Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. Ms. Wagoner currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.


----- 7 Pillars of an Effective Compliance Program for Healthcare Companies: Lessons Learned from a Prosecutor's Perspective
By COCOM 21 Mar 2014 - IFSQN.

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Logo URL
Event Organizer ComplianceOnline
Contact Name Referral
Contact Number +1-650-620-3915
Contact Email referral@complianceonline.com
Event Category Conference
Event State/City California
Event Country USA
Cost of Attendance $149.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703280?channel=IFSQN

Event Description


This healthcare best practices training will discuss the seven recognized pillars that a compliance plan should include and the details that will allow attendees to reduce their company’s potential liability under the Federal U.S. Sentencing Guidelines. Learn from examples of healthcare companies that did not have or follow an effective compliance plan and the resulting civil fines and penalties as well as government oversight and audits that ensued.

Why Should You Attend:

Attend this 60-minute webinar to understand the framework of an effective compliance plan. Attendees will gain a basic understanding of the impact on reducing potential civil fines and penalties and False Claims Act violations under the Federal U.S. Sentencing Guidelines. Learn how to have the right policies adopted across your organization and audit protocols that can be used as an effective compliance tool.
Attendees will hear from a former US Attorney on best practices to stay ahead of the OIG and lessons learned from companies that were not so lucky. Course attendees will also get insight into lessons learned from recent Corporate Integrity Agreements, regulations and recent civil fines and penalties.

Areas Covered in the Webinar:
  • Federal U.S. Sentencing Guidelines
  • The 7 Pillars
  • 2014 -2018 OIG strategic plan
  • OIG special advisory bulletin on excluded parties
  • Recent cases of civil fines and penalties
  • Recent Corporate Integrity Agreements
  • Section 6501 Affordable Care Act (Excluded Parties)
  • Cases of enforcement
  • OIG resources for an effective compliance plan
  • Costs for non-compliance
Who will Benefit:
This webinar will provide valuable assistance to all personnel in hospitals, academic medical centers, long-term care facilities, medical offices, practice groups, etc. The following titles will benefit
  • Compliance Officers
  • CEO
  • CFO
  • Privacy Officer
  • Human Resources Officer
  • Healthcare Counsel/lawyer
  • Office Manager
  • Risk Department
Instructor Profile:
Alice H Martin, Esq, founded Martin Compliance Consulting (MC2) in July of 2012 following her service as Corporate Compliance Officer and Chief Privacy Officer for RegionalCare Hospital Partners (2010-2012) and U. S,. Attorney (2001-2009) where she headed a nationally recognized Health Care Fraud Task Force. She is a former Alabama Circuit Court Judge. She received her J.D. from the University of Mississippi, and her B.S. in Nursing from Vanderbilt University. She is licensed to practice law in Alabama, Mississippi & Tennessee. She is certified in healthcare compliance (CHC) and healthcare privacy (CHPC). She is active in the HCCA and the American Health Lawyers Association. Ms. Martin is currently appointed as a Deputy Attorney General in Alabama and provides legal counsel to the Department of Examiners of Public Accounts in its implementation of Alabama's Recovery Audit Statute.


----- Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process
By COCOM 21 Mar 2014 - IFSQN.

Permalink
Logo URL
Event Organizer ComplianceOnline
Contact Name Referral
Contact Number +1-650-620-3915
Contact Email referral@complianceonline.com
Event Category Conference
Event State/City California
Event Country USA
Cost of Attendance $199.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701786?channel=IFSQN

Event Description


This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices.

Why You Should Attend:

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. However, there are ways to validate equipment already in use!
This webinar will discuss Equipment Calibration Requirements, Preventive Maintenance Requirements, when to use Calibration when to use Maintenance, what is Remedial Action for Out-of-Calibration Equipment, how to use of Calibration Standards to Save Cost.

Areas Covered in the Webinar:
  • Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification.
  • Equipment Calibration Requirements.
  • Equipment Preventive Maintenance Requirements.
  • Calibration vs. Maintenance: When to use Which One?
  • Remedial Action for Out-of-Calibration Equipment.
  • Use of Calibration Standards to Save Cost.
  • Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.
  • Equipment Preventive Maintenance Requirements.
  • Use of Calibration Standards to Save Cost.
  • Remedial Action for Out-of-Calibration Equipment.
  • Calibration vs. Maintenance: Which One?
  • Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel involved in process development or equipment calibration/maintenance:
  • R&D management
  • Engineering management
  • Production management
  • Production engineers
  • R&D engineers
Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.


----- The Regulation of Pet Food in the United States
By COCOM 21 Mar 2014 - IFSQN.

Permalink
Logo URL
Event Organizer ComplianceOnline
Contact Name Referral
Contact Number +1-650-620-3915
Contact Email referral@complianceonline.com
Event Category Conference
Event State/City California
Event Country USA
Cost of Attendance $299.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702224?channel=IFSQN

Event Description


This 90-minute training will provide an introduction to FDA’s rules governing pet food product development and formulation, manufacturing, labeling; and marketing and promotion. In addition to facility inspections and product recalls, the webinar will summarize and assess FDA’s enforcement activity in the U.S. pet food market paying particular attention to enforcement trends and risks.

Why Should You Attend:
This webinar focuses on FDA rules governing the development, formulation (including ingredients and food additives), manufacture, testing, labeling; and marketing and promotion of pet food in the U.S. It will include a comprehensive overview of the pet food label; FDA’s rules governing the use of labeling and promotional claims; facility inspections, product recalls; and FDA enforcement action.
Paying particular attention to the FDA’s recognition of new foods and ingredients, the webinar will also focus on the FDA’s regulation of food and food additives including the pre-marketing clearance requirement, the food additive petition process and the process for showing that an ingredient is Generally Recognized as Safe (“GRAS”). An introduction to the function and responsibilities of the Association of American Feed Control Officials (AAFCO) will also be provided.

FDA’s regulation of products marketed as veterinary dietary supplements or nutraceuticals will also be discussed including the use of health claims in conjunction with the promotion and sale of such products in the U.S. A summary of the FDA’s past enforcement activities including the 2007 melamine incident and an introduction to the animal drug approval process will also be provided.

Learning Objectives:
  • Obtain a basic understanding of FDA's regulation of pet food in the United States.
  • Learn what FDA requires to appear on the label of a pet food product.
  • Identify potential risks involved with the marketing and promotion of pet food products.
  • Become familiar with the process by which a new ingredient is approved or accepted for use in pet food in the U.S.
  • Understand the role of the Association of American Feed Control Officials (AAFCO) in the development, formulation and labeling of pet food and feed products.
  • Understand how FDA regulates those products marketed as veterinary dietary supplements or nutraceuticals in the U.S.
  • Obtains a basic introduction to the veterinary drug approval process.

Areas Covered in the Webinar:
  • FDA's regulation of pet food products including the rules covering product formulation, manufacturing, labeling and promotion.
  • The various components of a pet food label.
  • The process for introducing a new ingredient or feed additive to the market.
  • The differences between the Pre-Market Clearance Process, the Food Additive Petition Process and the process for having an ingredient deemed Generally Recognized As Safe (“GRAS”).
  • Update on the status of the Proposed GRAS Self-Affirmation Notification Program.
  • A summary of FDA's recent enforcement activity in the area and recent trends and areas of particular enforcement risks.
  • FDA's regulation of those veterinary products marketed and sold as dietary supplement and nutraceutical in the U.S.
  • A brief introduction to the animal drug approval process.

Who will Benefit:
  • Pet Food Industry Representatives
  • Regulatory Affairs Professionals
  • Consultants
  • Scientists
  • Research Analysts
  • State Department of Agriculture Officials
  • Investment Analysts and Venture Capitalists
  • Pet Food Formulators, Manufacturers, Labeler and Retailers
  • Foreign Manufacturers
  • Importers / Exporters
  • Ingredient Producers
  • Financial analysts and investors focusing on the pet, pet food, animal health and companion animal markets

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to both domestic and international food and ingredient manufacturers, formulators, labelers, distributors and marketers on regulatory issues related to the U.S. Food and Drug Administration’s regulation of pet food. This includes counseling clients on FDA’s regulation of pet food and ingredient manufacturing, testing, approval, labeling and promotion. He also has considerable experience related to the regulation of veterinary biologics including veterinary cellular and genetic therapies. He frequently presents and has published on such topics, and provides pro bono legal services to a national Thoroughbred horse rescue.


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