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The Center for Professional Advancement, 90 Minute Accredited Online Training
August 12, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
An Overview of Documentation Requirements in FDA Regulated Industries
In Conjunction with Wiley-Blackwell
August 12, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
90 Minute Accredited Online Training Who Should Attend
This overview online presentation will benefit professionals in various functions in the pharmaceutical, medical device, biotech and related industries, who are responsible for the writing, implementation or management of various types of documents. These functions include:
• Pre-clinical operations
• Manufacturing processes
• Regulatory
• Clinical operations
• QA/QC
• Documentation writers/managers
• Laboratory operations
• Auditors
Description
This 90-minute accredited training course presents anoverview of the main types of documents required in FDA regulations and guidances, in ICH guidelines and in ISO 9000. Based on industry best practices, this presentation will discuss ways to classify documents and will clarify the distinction between controlled and non controlled documents. The transition from manual systems to electronic systems and the impact of 21 CFR Part 11 upon documentation will conclude the course. Please note that details about the management and control of documents, and documentation systems are discussed in other technical public courses offered by CfPA.
Module 1: Requirements for written documentation as identified in:
• 21 CFR Part 211–cGMP for Finished Pharmaceuticals
• Quality System Regulations–QSR
• 21 CFR Part 58–Good Laboratory Practice
• FDA Guidances
• ICH Q7A–GMP for Active Pharmaceutical Ingredients
• Quality System Standards–ISO 9000
Module 2: Role of documentation and examples of main documentation types in:
• Pre-clinical operations
• Clinical operations
• Manufacturing processes
• Laboratory operations
Module 3: Impact of 21 CFR Part 11–Electronic Records and Signatures:
• Moving from a manual system to an electronic system
• Basic documentation requirements
• Need for validation
• Availability of documents during FDA inspections
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Renée B. Galkin, Quality Management Consultant
Renée B. Galkin is a quality management consultant with over twenty years experience in the pharmaceutical and medical device industries. Her areas of expertise include quality audits, quality programs, FDA regulatory compliance, GMP training, documentation systems management, strategic planning and organizational development. Prior to starting her own consulting business, Ms. Galkin held managerial positions with two major companies – Wyeth Pharmaceuticals, Inc. and Science Management Corporation (a multinational consulting firm). Throughout her career she had both domestic and international assignments . Ms. Galkin holds an MBA in Business Management from New York University, an MA in Education from Brown University and a Bachelor of Science in Biology from Northeastern University. She is a member of the American Society for Quality, the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE). As a consultant, Ms. Galkin provides training, auditing and compliance advisory services to companies worldwide. She also directs several technical courses offered by The Center for Professional Advancement (CfPA).
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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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salbers@cfpa.com
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