FDA 21 CFR Part 11 Training, Compliance Best Practices and Standards

21 CFR Part 11 Compliance Training

21 CFR Part 11 specifies requirements for handling records covered by FDA regulations that exist in an electronic form. The 21 CFR Part 11 compliance training offers an overview of these requirements for electronic systems and how to comply with them to ensure compliance. The training also provides good understanding of the computer system industry standards for data security, audit trails, electronic records and signatures, software validation etc.

The FDA regulation 21 CFR Part 11 has very specific requirements of what should be included along with an electronic signature. 21 CFR Part 11 compliance has to be implemented not just to avoid the rage of the regulator, but also to ensure that data captured electronically is accurate and precise. The 21 CFR Part 11 training provides an in-depth review of the requirements for electronic signatures, along with tools for cost-effective implementation.

The FDA has tightened its enforcement actions of late and non-compliance especially in areas of computer system validation and protection of records can result in 483s, warning letters, ban on importation /commercial distribution and so on. Thus highlighting the importance of training in understanding the 21 CFR Part 11 requirements and achieving compliance.

21 CFR Part 11 Applicability

21 CFR Part 11 regulates the use of electronic records and electronic signatures required by predicate rules (regulations such as GLP, GMP, GCP) governing manufacturing processes in FDA regulated industry.

21 CFR Part 11 applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of FDA regulated products by firms which choose to use electronic records or signatures. Therefore the training will be valuable for all of those professionals who use computer systems to perform their job functions. Regulatory personnel, clinical and quality managers, training staff, IT professionals, working in the health care, clinical trial, biopharmaceutical, and medical device sectors will benefit from attending this training program.

ComplianceOnline 21 CFR Part 11 Training Courses

Subjects such as 21 CFR Part 11 compliance are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by ComplianceOnline. ComplianceOnline offers these training programs in various formats, including: live webinars, training recordings, CDs, in-person seminars and more. Led by recognized experts and industry veterans with decades of experience in regulatory affairs and compliance, our training programs will offer staff and management an interactive platform to understand and discuss current industry standards.