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FDA 21 CFR Part 11

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In-Person / Webinar
Ended last Oct 24, 2019
USD  199.00


This webinar will show you that there is no sense in tackling the ‘keeping’ of the records, by trying to follow Part 11, because the record requirements must come from the parties who provide, create, or change the records.

If you are part of the process of ‘Collecting’ (e.g.: from study nurse to x-ray specialist), ‘Using’ (e.g.: from sponsor to report programmer, or statistician), or ‘Keeping’ (e.g.: from coder, software provider, to server and backup specialist), then this webinar will answer the questions: of how important your part is in this process, and how you can help the company safe resources and be compliant.

If an effort is made to collect research-, study-, patient- or other important records, they should be kept safe, in a controlled and organized way. That way is defined by the requirements.

The cost of lost data/records can be staggering; also, the mishandling of records or lack of safekeeping. Withdrawing or the wish of deleting could be a big problem too.

It is not only about data or records but different samples as well which must be managed in the same way.

There is never ‘one fits all’ but the FDA’s 21 CFR Part 11 is still perfectly usable after many years. The main reason for that is, that it points to the requirements of predicate rules.

You have to provide an assured level of quality right from the beginning of the process (collecting records); that at the end the inspector, with the Part 11 in hand, will find no negative observations.

  • Overview and Definitions
  • The reasons why only talking about records or data is not enough
  • The relationship between the owner or provider, the collector or user, and the keeper
  • The forgotten loop
  • Common mistakes and today's problems (including ‘Big Data’)
  • Best practices or the ideal process
  • Questions
  • Course Level - Overview of the relationship between the groups which take part in the process of providing, using and safekeeping of records and samples. The fundamental importance of requirements; who needs to provide them, and what they are used for.

  • Clinical Operations Professionals (from study nurse to x-ray specialist)
  • Clinical Quality Assurance Professionals
  • Data Management Professionals
  • Clinical Investigators and Clinical Investigator Site Staff
  • Sponsors Clinical Study Groups
  • Clinical Trial Statisticians and Statistical Programmers
  • Clinical Electronic Systems Developers (also Big Data)
  • Service Providers (for saving and maintaining any samples of importance)

Willi Ramseier is the pragmatic system thinker, project management skills, risk management know-how, expertise in CAPA system and QMS (quality management system), a consultant for general quality issues (especially for start-ups)

His assets :

Presenter, speaker, (SAS Stockholm; Allan Lloyd Amsterdam; DIA data Madrid, DIA Barcelona, ERES Roche)
Vendor Audits and Quality Reviews
Concepts for the quality management system, CAPA system, Change management, ISO9001:2015
Process management (Policies, SOP’s, SA entries, System Validation); Risk assessment and management; CAPA plans (create, review and approval); Equipment (inventories, qualification, validation); Documentation, Templates; Training (GxP, CSV, CAPA, Company rules, Project management methodology)
Variety of work :

IT projects (from quality assurance and validation to access concept and security)
Lab projects (pathology, CPU, DNA, RNA)
Clinical trial teams quality assurance (Report validation, endpoint adjudication, Web sites)
CRO’s (clinical research organization)

Use Promo Code RSKPM and get flat 10% discount on all purchases

For more detail please click on this below link:


Email: [email protected]

Toll Free: +1-510-868-1040

Special Offer

Use Promo Code RSKPM and get flat 10% discount on all purchases
For more detail please click on this below link:
Toll Free: +1-510-868-1040
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We enhance global compliance, where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety. Our interactive training sessions could be beneficial to corporations thriving in industries such as pharmaceuticals, drugs and chemicals, FDA compliance, medical devices, packaging and labeling, food and beverages, banking and finance, audits and inspections, recalls and crisis management and learning portal devoted to advancing quality learning through conferences and online training (webinars & webcasts) Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline.

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