- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
This system validation webinar training by the expert speaker will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement a computer system.
why should you attend
The requirements of FDA CFR Part 11 apply to the implementation and use of computer systems that are used to manage information that is to be submitted to the Agency (FDA).
By validating the systems you are assuring that they are functioning properly and are not posing a risk to patients or others. When a submission is made to FDA it is likely that the FDA will do an inspection and they will review the process validation documentation and procedures.
This computer system validation course will cover the procedures that are to be followed and discuss all of the documentation that is to be prepared to meet the requirements of this regulation. Typically a System Development Life Cycle (SDLC) will be used to identify the Tasks to be performed, Those responsible for the tasks including those that are Responsible for the contents, the Deliverables that are to be produced that establish the Documented Evidence that the Computer System is working as intended.
- Be able to develop a Validation Plan
- Contribute to the development of Specifications
- Follow Programming Standards, if programming
- Build and execute Test cases
- Install and operate the Systems
- Develop Ussr documentation
- Contribute to Change Control
WHO WILL BENEFIT
- IT Staff implementing and supporting these computer systems
- Users of the computer systems
- Quality Assurance Staff faced with auditing computer systems
- Vendors of these “Regulated “computer systems
Richard Chamberlain is the President, Executive Consultant Services, LLC Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning and Computer Systems Validation. Managed large-scale clinical projects including development and validation of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs. Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems. Assisted in the development and validation of numerous computerized systems in all GxP environments. Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for compliance to regulations. Familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs. Experience responding to FDA Inspections, 483s, and Warning Letters Use of tools such as Gap Analyses, Risk Management, and Quality Management.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.