Application of Critical Analysis in Deviation Management- 9 reasons why
Application of Critical Analysis in Deviation Management- 9 reasons why Introduction The Medicines & Healthcare Products Regulatory Agency (GMDP Symposium 2016) stated the common deficiencies found in deviation management systems and CAPAs as listed below: Deviations were not adequately documented and investigated, consequently the appropriate CAPAs were not implemented. The investigations lacked the […]
Data Integrity Work Shop
I attended a work shop on Data Integrity; this is a very challenging area for majority of pharma companies, these challenges vary from company to company. This is also a major area of focus for the regulatory bodies. Embedding data integrity in pharmaceutical QMS not only instils complete confidence in pharmaceutical products by the end […]
Data Integrity: Asset or Liability
Data Integrity: Asset or Liability Introduction Data integrity (DI) is fundamental in any pharmaceutical quality system; this ensures that medicines are of the required quality, safety and efficacy. Data integrity refers to the overall completeness, accuracy and consistency of data during its entire life cycle. The data lifecycle considers the entire phases in the […]
07 May 2016: Deviation Management Systems / CAPA
Setax Training Consultancy is holding a one day interactive workshop on Deviation Management Systems / CAPA. For further details, contact ibelemaemeh@setaxtrainingconsultancy.com
24-25 February 2016: 3rd African Pharmaceutical Summit, Kenya
Building competitiveness and enhancing markets Venue: Safari Park Hotel, Nairobi, Kenya.