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Quality Management and Compliance in the Pharmaceutical and Related Industries

  February 06, 2020  
CfPA- The Center for Professional Advancement, Edison, NJ
June 4-5, 2020

Who Should Attend?
This intensive course will benefit those who need to understand the responsibilities and functions of the Quality Unit in a pharmaceutical firm and how the quality organization impacts all areas of operations and works as a team to help assure the quality of the products and compliance to regulations within in the pharmaceutical manufacturing arenas and related products. This material is particularly suitable for chemists, pharmacists, engineers and administrators working in the following areas:
  • Research & Development
  • Process Development
  • Analytical Development
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Plant Operations
  • Purchasing
  • Engineering/Maintenance
  • Corporate/Plant Management

This course will also benefit personnel who manage these individuals as well personnel who are suppliers to the industry.

Course Description
Under the FDA systems-based inspection approach, the Quality system is one that is routinely audited. The fact that quality issues are a huge factor in FDA 483 observations as well as product recalls for drugs, biologics, medical devices and cosmetics indicates that not all companies are meeting FDA’s current GMP expectations. Clearly a better understanding is needed to overcome this trend and ensure compliance for your company.

This 2-day intensive course provides the basic principles and practices of Quality Assurance, Quality Management, Quality Control and use of robust Quality Systems in the pharmaceutical industry. The presented material also applies to the biopharmaceutical, diagnostic, device and cosmetic industries and to suppliers, including API manufacturers. Discussions will include the role of quality, major elements of pharmaceutical quality, the impact of management practices, the features of an effective quality organization, quality management throughout the product life cycle, and the role of corporate quality. This course discusses current quality issues including company reorganizations, outsourcing, the evolution of FDA approaches, global standards and the use of such techniques as Risk Management, Quality-by-Design and the Quality System approach. The course is presented in an open, interactive manner, encouraging discussion throughout. Three mini workshops will be provided to address how to create Quality Documentation that meets FDA’s current Expectations.
Organized by: CfPA- The Center for Professional Advancement
Invited Speakers:
    Bettina Kaplan, President, BKK Consulting

Bettina Kaplan is President of BKK Consulting, LLC, providing guidance and assistance in implementing new and improved Quality Systems in the Pharmaceutical, Bio-Medical and Medical Device arenas. Ms. Kaplan has 36 years of experience in the QC, QA and Compliance areas working with Hoffmann-LaRoche, Sandoz, Schering-Plough and Purdue Pharma, as well as medium, small-size and start-up companies in positions of increasing responsibility, including Vice President. Some of the key accomplishments Ms. Kaplan has seen in her career are:
  • Re-building various QA/QC/Validation/Compliance groups after serious regulatory issues
  • Creating an FDA-compliant R & D Quality & Compliance Group for a large pharmaceutical organization
  • Setting up Supplier Management programs to meet current regulatory requirements
Ms. Kaplan has a BS Degree from Stevens Institute of Technology in Chemistry and has completed various Business Management courses over the years. She was a key contributor to a National Science Foundation Research Grant “New Jersey’s High Cancer Rate, Possible Causes and Early Biochemical Detection Methods”. Additionally, she has completed the NJPQCA Certification Course and a Quality Master’s Course given for the Novartis Group of Companies. She has sat on the board of NJPQCA for eight years and held various key board positions including the Chairperson of the organization.

Ms. Kaplan is a member of the following organizations - NJPQCA, ASQ, ISPE and ACS.
Deadline for Abstracts: N/A
Registration: Please click here for registration information.
E-mail: knee@cfpa.com
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