Data integrity in pharmaceutical industry I 30 Interview questions and answers
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Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : [ Ссылка ]
2. QA- Quality assurance in Pharmaceutical industry. : [ Ссылка ]
3. QC - Quality Control in Pharmaceutical industry : [ Ссылка ]
4. OSD - Tablet Manufacturing in Pharmaceutical industry : [ Ссылка ]
5. Injectable processing - Injectable processing or Sterile dosage formulation : [ Ссылка ]
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Questions covered:
Q. What is data integrity in the pharmaceutical industry?
Q. Which regulatory guidelines emphasize / focus on data integrity?
Q. Provide a data integrity violation example ?
Q. Which are the Key elements of data integrity according to FDA's guidance?
Q. What does ALCOA plus stand for in data integrity?
Q. How does EU Annex 11 address data integrity?
Q. What is difference between GDP error and data integrity issue?
Q. State any examples of GDP error and data integrity issue?
Q. Which are the important steps in investigating data integrity breach / violation ?
Q. What is a CAPA plan for data integrity issues ?
Q. What should be the corrective and preventive actions in case of data integrity violation ?
Q. How to ensure proper documentation of investigation findings?
Q. What is role of training in preventing Data integrity violations?
Q. What is role of automated audit trails in prevention of data integrity violations ?
Q. How to control or prevent unauthorized data access?
Q. What are the considerations for implementing data integrity controls?
Q. What are the consequences or impact of data integrity violation on pharmaceutical industry ?
Q. What is importance of routine data integrity assessments?
Q. What is advantage of ensuring data integrity in batch records?
Q. What is impact of data integrity issues on product release?
Q. How to implement data integrity controls in paper-based documentation?
Q. What is purpose of electronic audit trail?
Q. How to cultivate or maintain a culture of data integrity?
Q. What is Senior management's role in promoting data integrity?
Q. What is purpose of internal data integrity audit ?
Q. How to get prepared for regulatory inspections on data integrity ?
Q. How to address data integrity findings post-inspection?
Q. How data integrity is maintained in automated instruments?
Q. Which are the five main reasons for data integrity violation in pharmaceutical industry ?
Q. Which Guideline are commonly referred for Data integrity in pharmaceutical industry ?
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