Course Title: FDA/CGMP Drug (Pharmaceutical) - Implementation and Audit/Auditor (21CFR210-211)

CEU: 2.0

Prerequisites:  None

Course Time Period:

You can take training at your own pace. You can logon and logout as many times as needed. You can re-take the exam as many times as necessary until you pass the exam and an online certificate is issued.

Key Session Topics:

Definitions
What are the CGMP requirements?
What are the Responsibilities of Quality Control Unit requirements?
What are the Personnel Qualifications requirements?
What are the Personnel Responsibilities requirements?
What are the Consultants requirements?
Audit Questions
What are the Design and Construction Features requirements?
What are the Lighting requirements?
What are the Ventilation, Air Filtration, Air Heating and Cooling requirements?
What are the Plumbing requirements?
What are the Sewage and Refuse requirements?
What are the Washing and Toilet Facilities requirements?
What are the Sanitation requirements?
What are the Maintenance requirements?
Audit Questions
What are the Equipment Design, Size, and Location requirements?
What are the Equipment Construction requirements?
What are the Equipment Cleaning and Maintenance requirements?
What are the Automatic, Mechanical, and Electronic Equipment requirements?
What are the Filters requirements?
Audit Questions
What are the General Requirements for Control of Components and Product Containers and Closures?
What are the Receipt and Storage of Untested Components, Containers and Closures requirements?
What are the Testing and Approval or Rejection of Components, Containers and Closures requirements?
What are the Use of Approved Components, Drug Product Containers and Closures requirements?
What are the Retesting of Approved Components, Product Containers and Closures requirements?
What are the Rejected Components, Drug Product Containers, and Closures requirements?
What are the Drug Product Containers and Closures requirements?
Audit Questions
What are the Written Procedures and Deviations requirements?
What are the ChargeIn of Components requirements?
What are the Calculation of Yield requirements?
What are the Equipment Identification requirements?
What are the Sampling and Testing of InProcess Materials and Drug Products requirements?
What are the Time Limitations on Production requirements?
What are the Control of Microbiological Contamination requirements?
What are the Reprocessing requirements?
Audit Questions
What are the Materials Examination and Usage Criteria requirements?
What are the Labeling Issuance requirements?
What are the Packaging and Labeling Operations requirements?
What are the TamperEvident Packaging Requirements for OTC Human Drug Products?
What are the Drug Product Inspection requirements?
What are the Expiration Dating requirements?
Audit Questions
What are the Warehousing Procedures requirements?
What are the Distribution Procedures requirements?
Audit Questions
What are the General Requirements for Laboratory Controls?
What are the Testing and Release for Distribution requirements?
What are the Stability Testing requirements?
What are the Special Testing Requirements?
What are the Reserve Samples requirements?
What are the Laboratory Animals requirements?

FDA/CGMP Drug (Pharmaceutical) - Implementation and Audit/Auditor (21CFR210-211) Final Exam

Certificate Issuance: Online Certificate is issued upon completion of course and Final Exam

Courses Approval: All courses are approved by Quality University and the certificate issued has Quality University registered mark and certificate number.

Please follow instructions below for taking the course:

• Make sure you create a separate login account for each person taking the course. The name on the account should match the name of the person who is taking the course and whose name will appear on the certificate. Once created the contact name cannot be changed and the course cannot be reassigned to a different name.
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course.

You can logon and logoff as many times as needed until the course is complete. In order to continue a course already in progress after you have logged off:

• log into Quality University through by clicking the "My Account" link
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course. You may take the course and exam at your leisure.

You may retake the exam as many times as needed until a passing score is achieved.

For additional questions, you may contact us at our Help/Support Link located on the bottom of the Homepage.

Once you complete the course with a passing score on the exam you will be issued a certificate. Please print this cerificate for your own records. If you need to reprint a certificate for any reason, visit the "My Courses" link and you will have an option to reprint a certificate for any training you have completed.

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• Microsoft Internet Explorer
• Make sure all Pop-Up Blockers are disabled
• For any troubleshooting, refer to Help/Support at:http://www.qualityuniversity.com/commerce/misc/onsite.jsp
• If screen is blank, exit Internet Explorer and log back in again

• log into Quality University through by clicking the "My Account" link
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course. You may take the course and exam at your leisure.

Please follow instructions below for taking the course:

• Make sure you create a separate login account for each person taking the course. The name on the account should match the name of the person who is taking the course and whose name will appear on the certificate. Once created the contact name cannot be changed and the course cannot be reassigned to a different name.
• Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
• Select your course.

You may retake the exam as many times as needed until a passing score is achieved. All courses are approved by Quality University and ISO Accelerate Group.

For additional questions, you may contact us at our Help/Support Link located on the bottom of the Homepage.

Once you complete the course with a passing score on the exam you will be issued a certificate. Please print this cerificate for your own records. If you need to reprint a certificate for any reason, visit the "My Courses" link and you will have an option to reprint a certificate for any training you have completed.