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CfPA-The Center for Professional Advancement, Burlingame, CA
October 16-18, 2017
Who Should Attend?
This practical course is intended for professionals in the pharmaceutical, biotechnology, dietary supplements, cosmetic and related industries, including:
• Supervisory and training staff
• Management level staff – all departments
• Investigation Writers and reviewers
• Validation staff
• Internal auditors (site and corporate)
It is most beneficial to manufacturing personnel involved in:
• Manufacturing operations including packaging and the laboratory
• Writing validation documents (including Master Plans)
Higher level technical and managerial personnel will find the course a worthwhile overview of the basics based on new FDA guidance effective 2011.
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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 | Joanna Gallant; Owner & President, Joanna Gallant Training Associates, LLC |
Joanna Gallant is a solutions-driven Quality and Training professional with over 20 years of technical and operational experience. She is an experienced training leader with a demonstrated ability to succeed and solve problems, and is known for designing, developing and delivering strong, interactive and effective GxP/ISO-related training. Over her career, she has provided regulatory, technical, skill, and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management. She regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based and interactive training. Ms. Gallant is fluent in a variety of global regulations and standards, including US, EU, PIC/S & WHO GMP; 21 CFR 11, 58, 600, 803, 820 & 1271; ISO 13485, and ICH Q7-10.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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jmorbit@cfpa.com
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