| |
|
|
|
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
22-23 April 2020
Who Should Attend?
This course is designed for professionals in the Pharmaceutical, Biotechnology, and related industries who have responsible for or input into an Annual Product Review or Product Quality Review. It will be especially beneficial to individuals in the following areas:
• Quality Assurance
• Quality Control
• Management
In addition, managers and supervisors of the above professionals would likewise benefit since the training will help them better guide and evaluate their personnel.
Suppliers to these industries will also find the training very worthwhile. Course Description
|
|
|
|
|
|
|
|
Organized by:
|
|
CfPA-The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
 Kimberly Johnson, M.S. RA/QA, CQA, Consultant to the Pharmaceutical Industry |
Kimberly Johnson, is an industry veteran and specializes in the areas of Quality Assurance and Quality Management Systems. Prior to consulting, Ms. Johnson has been in the industry 25+ years serving in numerous quality management roles with start ups to Fortune 500 companies (DepoTech, Bristol Myers Squibb, Wyeth, Purdue Pharma, Watson Laboratories, Inc., Pii and Cambrex) managing combination products, medical devices, parenterals and pharmaceuticals (solid and liquid oral, topical and transdermal).
Ms. Johnson is skilled in the development, implementation, maintenance and continuous improvement of Quality Management Systems that include Audits & Inspections, Document Management, Change Management, Risk Management, Corrective and Preventive Action and Effectiveness programs, Deviations and Investigations, Complaint and MDR Handling, Supplier Qualification, Data Integrity and Quality System Management Metrics and Trending.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
N/A
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
Jmorbit@cfpa.com
|
|
|
|
|
|
|
|
|
The US and EU regulations will be addressed, followed by a discussion of how various pharmaceutical companies manage their APR/PQR system.
Discussions will include:
• regulatory expectations and citations
• what information to collect
• how to incorporate quality risk management
• what metrics to use in the report
• how to structure the report with model examples
• when and how to issue it
• proper follow up
• case studies
This course encourages open discussions and an interactive environment.