Who Should Attend
Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions) should attend. This two-day course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management.
Learning Objectives
Upon completion of this two-day course attendees will increase their ability to implement efficient practices that meet full GLP/GMP/ICH, ISO, and other regulatory requirements. In addition, participants will better understand:
- The 21 CFR Part 11 Electronic Records; Electronic Signatures, Final Rule requirements for managing documentation electronically, and the FDA’s predicate rules, such as 21 CFR Part 211, 58, and 820
- The common ground in all regulations, including the International Conference on Harmonisation (ICH) guidelines, the International Organisation for Standardisation (ISO), and the new HIPAA regulations for electronic records 45 CFR Parts 160, 162, and 164 Health Insurance Reform: Security Standards: Final Rule
- What is required to establish a sound documentation function within your work arena
- How electronic documentation systems work and what’s needed to keep them compliant
- How to go from a manual system to an electronic system
- What documentation must be in place to support the documentation function
- What documentation must be in place to support the company’s systems and processes
Course Description
If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don’t tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.
This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.
 View Course Agenda
Past Participants' Comments
"This course is well organized and very thorough. The Course Director is very knowledgeable and there wasn’t a single question she couldn’t handle…and she was asked a lot of questions! This course surpassed my expectations and I’m definitely recommending it."
Sara M., Clinical Documentation Coordinator, Sanofi-Pasteur
"This was a fabulous course! I learned a lot and I’ve come away with even more questions! I learned that I need to learn a lot more and I hope to take more training through your company. Thanks so much!"
Roxanne M., Project Admin. Assistant, BioMS Medical Corp.
"My rule of thumb for measuring the success/worth of the seminars/courses I attend is the ability to take 2-3 good useable concepts back to my company to improve our processes. From this course, I have numerous improvements/concepts to take back. I'm confident my company has/will receive full payback from sending me to this course."
Sandra M., Document Control Supervisor, Alcon
"This course definitely opened my eyes! I know documentation is important but I didn't have the appreciation for its importance that I do now. I'm much more aware of all the things we'll need to think about, especially for a new company. I also attended the Writing SOP's course. Thanks for two great classes!"
Michael B., QA Manager, Phage Biotechnology Corp.
"While no course is able to customize content to cover every student's needs, I was pleased to have the instructor learn how the student's each worked and which areas had the most relevance for each. She zeroed in on those key areas that had the most value for the individual's situation as we can to those parts of the course."
Paul G., Otsuka America
“The course content was very well tailored and presented. I cannot think of anything to make it better. The whole thing was very meticulously planned and executed.”
Dinesh G., Senior Validation Engineer, Organon Pharmaceuticals
“The Instructor was very knowledgeable about compliance issues and gave some very good ideas. I enjoyed the class very much.”
Sue B. Clinical Documentation Coordinator, Aventis
"This course provided me with ideas on how to improve my organization’s document control function, making sure we are compliant with regulatory agencies and how to implement an electronic document management system."
Tara D., Document Control Specialist, Tengion, Inc.
"I really enjoyed the course in that it provided the big picture to how a DMS should be set up and what factors are involved. This course, I believe, is a good foundation course for anyone who will be dealing with documents."
Linh T., Documentation Specialist, Forbes Medi-Tech
"The Course Director was knowledgeable and the class material was excellent. Every course I have taken with CfPIE has been informative."
Donna G., Clinical Documentation Coordinator, Sanofi-Pasteur
"I found the course and Course Director very interesting and informative. I have a much better understanding of Document Management and E-systems. This has given me the tools I need to present information on e-systems and the ability to assist in the implementation."
Cheryl M., Supervisor, Document Mgmt. Group, Bristol-Myers Squibb
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