21 CFR Part 11
21 CFR Part 11 FDA has communicated the intention to step up enforcement on numerous regulations including those for electronic records and autographs. Indeed if you missed the first surge of Part 11 fever in the late 1990’s, it’s not too late to catch up now!
.In this free webinar, you’ll learn why was enacted in the first place, and how the FDA’s enforcement has changed over time.
You’ll come to understand the detailed conditions within Part 11 for electronic records, electronic autographs, and open systems.
We’ll also give a step-by- step approach for how to launch and execute your own Part 11 compliance action.
And eventually, we will review recent FDA Warning Letters for electronic record issues, so you can help your company from making the same miscalculations.
Part 11 Webinar Topics
The history of When and why was this regulation legislated?
What records and autographs does Part 11 apply to? And, what records and autographs are outside the compass of the regulations?
. Part 11 specialized, procedural, and attestation conditions for electronic records, electronic autographs, and open systems
.FDA Guidance on compliance with Part 11
Step by step methodology for executing your Part 11 compliance design
Metrics and trends in the FDA’s enforcement.
Exemplifications of recent FDA Warning Letters for electronic records violations
Studies on the future of Part 11
Preface to 21 CFR Part 11 Electronic Records; Electronic Autographs
This course is delivered on- demand, at your convenience, in 1 module. The module will deliver information to you, let you tone- assess your knowledge with review questions interspersed throughout the module, and will crown with a quiz at the end of the module.
Target Audience Quality Assurance professionals, IT, business system possessors, and operation who use GxP- validated systems and would profit from an preface to the principles.
Description This is an introductory course that explains the contents of (Electronic Records; Electronic Autographs), including the compass, Corridor, and delineations of the crucial terms used in Part 11, and provides real- life exemplifications of how to apply Part 11 principles. This course will test your knowledge of Part 11, and successful actors will admit a instrument of completion.
Objects
The module objects are defined at the morning of the module. By the end of the module you will be suitable to negotiate the following objects
Outline the contents of 21 CFR Part 11
Define crucial terms in Part 11
Describe how to apply Part 11 principles
FDA 21 CFR Part 11 Training, Compliance Best Practices and Norms
. FDA 21 CFR Part 11 regulation grounded webinars, in-person forums, norms and stylish practices. Learn from famed experts about FDA conditions for computer systems and their compliance-21 CFR Part 11, Electronic Records and Autographs, Standard Operating Procedures ( Bribe), Master Product Batch Record (MPBR), Attestation, Part 11 examinations, etc.
21 CFR Part 11 Compliance Training
21 CFR Part 11 specifies conditions for handling records covered by FDA regulations that live in an electronic form. The 21 CFR Part 11 compliance training offers an overview of these conditions for electronic systems and how to misbehave with them to insure compliance. The 21 CFR Part 11 training also provides good understanding of the computer system assiduity norms for data security, inspection trails, electronic records and autographs, software confirmation etc.
The FDA regulation has veritably specific conditions of what should be included along with an electronic hand. compliance has to be enforced not just to avoid the rage of the controller, but also to insure that data captured electronically is accurate and precise. The training provides an in- depth review of the conditions for electronic autographs, along with tools for cost-effective perpetration.
The FDA has tensed its enforcement conduct of late and non-compliance especially in areas of computer system confirmation and protection of records can affect in 483s, advising letters, ban on importation/ marketable distribution and so on. Therefore pressing the significance of training in understanding the conditions and achieving compliance.
21 CFR Part 11 Applicability
21 CFR Part 11 regulates the use of electronic records and electronic autographs needed by predicate rules ( regulations similar as GLP, GMP, GCP) governing manufacturing processes in FDA regulated assiduity.
21 CFR Part 11 applies to all aspects of the exploration, 21 CFR Part 11 clinical study, conservation, manufacturing, and distribution of FDA regulated products by enterprises which choose to use electronic records or autographs. Thus the training will be precious for all of those professionals who 21 CFR Part 11 use computer systems to perform their 21 CFR Part 11 job functions. Regulatory help, clinical and quality directors, training staff, IT professionals, working in the health care, clinical trial, biopharmaceutical, and medical device sectors will profit from attending this training program.
Compliance Online 21 CFR Part 11 Training Courses
Subjects Similar as compliance are multi-faceted and complex and can be more understood after attending a training course similar as the bones offered by Compliance Online. Compliance Online offers these training programs in colorful formats, including live webinars, training recordings, CD sin-person forums and further. Led by honored experts and assiduity stagers with decades of experience in nonsupervisory affairs and compliance, our training programs will offer staff and operation an interactive platform to understand and bandy current assiduity norms.