Regulatory Compliance Basics for Medical Device, Pharmaceutical, Biologic, and Combination Product

December 03, 2018

CfPA-The Center for Professional Advancement, New Brunswick, NJ or Virtually
May 2-3, 2019

Who Should Attend?
Professionals in the Pharmaceutical, Biologic, Medical Device and Combination Products industries who will benefit most by attending this course include:
  • Senior management, RA, RC, QA, QC
  • Quality, Manufacturing, and Design engineers
  • Sales and Marketing, Maintenance, and Operational personnel, and
     Healthcare professionals, and
  • Anyone else who manages, assesses, or performs any related quality work.

Course Description

This 2-day accredited training will offer the basics of U.S. and international pharmaceutical, biologic, medical device, and combination product quality and regulatory compliance concepts. You will also learn the history, purpose, and scope of U.S. FDA laws, regulations, directives, standards, and guidance, an overview of U.S. and international quality, quality system, and regulatory compliance concepts, the types of FDA regulated products, basic quality, regulatory and administrative requirements, and what is expected to bring a pharmaceutical, biologic, medical device, or combination product to the U.S. marketplace. Not only will there be a lecture and discussion, but also case studies, problem-solving workshops, and hands-on work using the computer in order to determine a) whether a product is an FDA regulated product, b) the classification scheme for an FDA regulated product, c) the market submission requirements for an FDA regulated product, and d) the quality system requirements for an FDA regulated product.

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

George Calafactor, Former FDA Investigator, Regulatory Compliance Consultant

George Calafactor is a 32-year food, cosmetic, drug, biologic, clinical, and medical device non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 10 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor.

Mr. Calafactor’s educational background includes 2 BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame, an MBA in International Business from Indiana University, and a MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices with a concentration in Regulatory Compliance from Northeastern University.

Mr. Calafactor not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical facilities, but has also performed various pharmaceutical and medical device quality assurance and regulatory compliance operations, such as monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, reconciling and analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, and informing management and staff of current FDA and EU enforcement policies.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

Jmorbit@cfpa.com

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