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Saturday, January 19, 2019
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21 CFR Part 11: Auditing for Part 11 Compliance (ESR06)

Certification Training Duration: 1.4 hours (the average time to complete the training program, including final assessments).
Credits Hours: 1
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: 21 CFR Part 11: Auditing for Part 11 Compliance
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

Technology is playing a more significant role in compliance than ever before. This is why proper preparation and documentation of electronic signatures and electronic records must be done in accordance to 21 CFR Part 11, an FDA regulation. The 21 CFR Part 11: Auditing for Part 11 Compliance Course will teach students what inspectors and auditors look out for during inspections. To receive your certification, learners are required to pass an online, multiple-choice final assessment after completing the presentation phase of the course.

Benefits of Getting Certified at BioPharma Institute

Throughout each course, students will engage in active learning with the aid of tools, such as recorded webinars, high-quality animations, videos, online books, and more. At BioPharma Institute, we cater to both small-scale and large-scale training requests. Our online training solutions can be customized based on your unique requirements. Since our inception, we have been one of the top online training institutes for professionals working in the pharma, biotech, and healthcare industry. We have assisted thousands of businesses to train their employees. You can rest assured that our certifications are recognized by a wide spectrum of companies, in a variety of industries.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The 21 CFR Part 11: Auditing for Part 11 Compliance course is found in the following professional certification program(s):


COURSE OUTLINE:


About 21 CFR Part 11.
– Planning fo audits
– Tools for successful audit.
– Preparing for the audit.
– Executing the audit.
– CAPA and close of the audit.
– What to expect for responses.
– Common audit findings
– Common pitfalls.

COURSE OBJECTIVES:


The objective for this training is to provide the learner with a deeper knowledge within this subject matter.


For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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