Industries: Pharma / BiotechMedical Device

Effective Document Management for Pharma, Biotech & Medical Device

Course Director: Kay Monroe

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

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 pharmaceutical document management course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.

This pharmaceutical document management 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.

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 effective document management course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management.

Course Agenda

First Day

  • Implied and explicit regulatory requirements for documentation
  • Industry standards
  • Documentation from discovery through marketplace
  • Management support
  • The documents you need to control, from source data to dossiers
  • Components of document systems
  • System administration
  • Document review, approval, and revision
  • Document distribution, retrieval, and archiving
  • Determining "how it needs to happen here"

Second Day

  • Going electronic from a manual system
  • Features of electronic record keeping
  • Understanding e-system requirements: validation, security, accountability, and audit trails
  • Validation documents
  • Standard Operating Procedures and other documents to support the system
  • Writing sound procedures
  • Consistency in format and terminology
  • Training requirements and training documentation
  • Remaining "inspection ready"
  • Auditing the system
  • The system over time: anticipating change

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


"Excellent material and excellent instructor. The class was very interactive." Diane P., Manager Quality Assurance, Zyla Life Sciences
"I found this training quite helpful and plan to take a lot of this back to implement at Novavax." Cassandra G., QA Documentation Specialist, Novavax
"The course director was very knowledgeable and accommodating to our schedules. She efficiently covered all the information and answered all of our questions." Janna S., QA Associate, Seattle Genetics
"The course is well structured and covers all aspects of document management." Marco B., GxP Manager, Menarini Ricerche
"This was great! Managing effective documents isn't the most exciting topic in the universe, but this course made it interesting and put it in a frame of reference that I could understand as a person who is new to this industry." Norah B., Quality Document Associate, Allena Pharmaceuticals
"The instructor was very knowledgeable and friendly, she engaged the class in conversation and participation." Pam E., Senior Project Administrator, C.R.Bard
"This Course Director is unique. Extremely professional and yet, down to Earth and intuitive to this particular group's needs and desires. She is challenging and respectful, to say the least. I hope to be tutored by her again in the near future!" Jan G., Quality Specialist Doc Control, PCI Pharma Services
"It was an excellent course for individuals starting out in the documentation for medical devices field. The supporting materials enable the learner to venture further into the direction of his/her knowledge needs by providing reliable and timely sources for further investigation." Stephanie P., Documentation Manager for R&D, Sonova
"I really enjoyed the section of the course where each group created process maps for their current processes. We compared them to the other groups to see where we could go back to our individual Company's and possibly stream-line our own process. I found this to be very collaborative, fun, and useful." Lindsay, Quality Assurance Achivist, Regeneron
"The Instructor was very knowledgeable on both topics as it related to both systems and industry standards. She was able to keep a very diverse group engaged and interactive. Will be looking at other courses for certification and would definitely recommend the course to others." Sharen, S. Submission Specialist, West Pharmaceutical Services
"The course instructor was an expert! The training binder was splendidly organized - having the handouts filed inside the binder was a great idea!" Manny R., QADC Associate Manager, MacroGenics
"This course was great! I learned a lot about documentation and validation. I would recommend to others. The instructor is great and very knowledgeable. Overall, it was a very informative, learning experience." Niyati P., QA Document Control, Onconova Therapeutics
"Very valuable information. Really enjoyed the discussion and the way the instructor facilitated the discussion. I learned a lot, not just from the instructor, but also the other classmates." Amanda W., Technical Writer, Genentech
"The course provided me with tools that will make my job as a document control specialist better. I am excited to get back to my office to utilize the tools and knowledge I have gained." Sherrie S., Document Control Specialist, Ikaria
"The Course Director did a great job presenting the subject matter. It's interesting to be in a class with like-minded people (and instructor) in my area (Doc Control)." Thomas G., Sr. Manager DCLS, BioiMemetic Therapeutics
"I liked the Course Director's professional and knowledgeable explanations. There were plenty of interaction opportunities as a group. She has a very calm, confident manner that I found reassuring. I enjoyed the class and am taking away information that I will need to go forward in my current position. This has filled in the gaps for me, and I have some ideas that I will share with my coworkers." Maureen F., QA Specialist, VaxInnate
"The Course Director is very knowledgeable, and she really makes her courses very interactive. I highly recommend her." Koleen F., Clinical Operations, Acorda Therapeutics
"The course was informative, interesting, and a great instructor!" Rhonda H., Document Control and Training Specialist, Ikaria
"This was a big picture view of document control for all aspects of a pharma company. I have a small piece, i.e., document control administration and some tasks with SOPs. This class showed the gaps in my knowledge of all processes and how they should be linked together. As I continue to grow in this position and become knowledgeable, I will become more value-added to my company. Instructor was awesome - knowledgeable, friendly, engaging!" Kathleen S., Document Control, Santen
"The course instructor was very informative and engaging the entire time. She showed interest in all of the students and was clear to see she wants the best for us. She was happy to share her information and contacts she has built over the years. I'm looking forward to attending her other courses." Lyndsay S. – Associate CDMS Doc. Coord. – Pfizer
"Great course, great instructor! Looking forward to coming back for another course!" Jessica B. – Records Management Team Leader – Pfizer
"I think the training gave me feedback that we are working in the right way with our Document Management System and also tools on what we can approve and how to do it." Ann E. – Document Management Specialist – Nobel Biocare AB
"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

Frequently Asked Questions

Does the course cover how to evaluate and choose a document management system?

Not specifically. Participants discuss the pros and cons of the systems they are using and/or are familiar with, as does the instructor. The course does focus on what documentation systems should do for your company, how to set them up from scratch on paper, or using a hybrid paper/software system and preparations for merging existing systems into new systems.

Is the Trial Master File (TMF) covered in this course?

Not in detail. There is a separate class specifically geared to understanding the TMF and implications for submissions as well as documentation systems. This course discusses the fit of the TMF in the overall document system.


CfPIE Document Management Systems Course

In this video, both an attendee and Kay Monroe, a pharmaceutical industry veteran and the instructor of our “Effective Document Management Systems” course, discuss the benefits of our approach to training courses.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.