Pharma Industry Interview Question & Answer Part 11 (Training)

Data Integrity App

Question 01: 

What training is expected of the relevant personnel?

Best Answer: The relevant personnel should know the main regulations concerning their tasks and be able to demonstrate the internally required qualifications to perform the tasks in question. This already arises from the general GMP requirements over and above Annex 11.

 

Question 02: 

What does 'necessary qualifications' mean?

Best Answer: 'Necessary qualifications' mean having the education, training, experience and skills or any combination of these elements that will ensure that staff can perform assigned duties and functions at an acceptable level.

 

Question 03: 

What are the training requirements for personnel?

Best Answer: Training and assessment should be carried out by persons with relevant training, qualifications and experience in the subject matter and training personnel should preferably have been formally qualified in training and assessment.

Training should be given to all people affected by significant change in the Quality Management System, e.g. when SOPs or methods of manufacture change. The requirement for initial and ongoing training should be reflected in procedures, and training records should be generated and kept.

There are a number of people who have a direct bearing on quality outcomes. These include contractors, consultants and casual employees. Therefore, appropriate training and assessment should be provided and recorded.

 

Question 04: 

What role has a Quality Personnel to play in validation?

Best Answer: The Quality Personnel does not have to play a formal role in validation. But inclusion of a Quality Personnel is recommended as it is the task of the QP to finally release the manufactured product. This release can only be authorized knowing the quality systems used for the proper validation.

 

Question 05: 

Does the QP substitute QA in validation?

Best Answer: The exact responsibilities need to be laid down in the operation procedures. Annex 11 proposes a division into roles that may, however, be independent of a QP and/or QA.

Thus the role of the QA has to be defined internally and independently of the function of a QP.

 

Question 06: 

What are language requirements for personnel?

Best Answer: Manufacturers should define language requirements or standards and ensure personnel are proficient in the required language for their allocated tasks, particularly in relation to documenting and recording. Procedures employed to overcome identifiable deficiencies should also be documented.

 

  

“Trust but Verify “ Ronald Re

 

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Data Integrity App

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

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- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

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