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 810
- 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:
"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 perfect 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
"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
"The Course Director was excellent – very knowledgeable, personable and engaging. The Course was very well presented and the course material was very well organized. I will take more courses with CfPIE and would highly recommend both the Center and the Course Director. Thank you for an information-packed, very worthwhile course!"
Heidi A., Sr. Document Control Specialist, Ceregene
"After 10 years as a Documentation Manager, I finally got the opportunity to take what should have been the course I started my career with."
Eric E., Documentation Specialist II, Xencor, Inc.
"The information provided in this course is priceless, there is none like it! This course has provided me with all the answers without having to ask the questions."
Ken C., Documentation Manager, Xoft, Inc.
"This course was very informative and had strong course material. It was one of the best courses I have attended. The instructor was extremely knowledgeable which made a huge difference."
Maria T., EC Writer, Abbott Labs
"This was an amazing course. Once I completed the course, I felt as though I had gained enough knowledge of the material to really implement drastic changed in our document management."
Rhonda T., Quality Assurance Analyst, AMCOL MBS
"This course is definitely a 'document intensive" educational tool. Both days of the course referred to extremely valuable information which can be applied from clinical to the manufacturing areas. The instructor was very knowledgeable and ran an extremely interactive course which I thought was great!"
Dorothea G., Senior Clinical Trials Coordinator, Targacept
"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
"I found the course and Course Director very interesting and informative. I now have a much better understanding of Document Management and E-systems. This course 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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