1.What is training ? Why it is needed ?
Training: Training is a tool/way to know something to increase our knowledge or skill.
Importance of training:
Training helps to provide an opportunity and broad
structure for the development of human resources technical and behavioral
skills in an organization. It also helps the employees in attaining personal
growth.
2.What are the functions of Qualified and
key personnel in a Pharmaceutical Industry ?
I.A qualified
person must ensure that each batch has been produced & tested/ checked in
accordance with the directives & marketing authorization
II.A qualified
Person musr certify in a register or equivalent document as operations are
carried out & before any release that each production batch satisfies under
the requirement of GMP
Functions of key personnel in a Pharmaceutical
Industry:
I.To ensure that
the production records are evaluated and signed be an authorized person before
they are sent to the QC department.
II.To check the
maintenance of his department, premises and equipment.
III.To ensure
that the appropriate validations are done.
IV.To approve or
reject, as sees fit, starting materials, packaging materials. And intermediate,
bulk & finished products.
V.To evaluate
batch records.
VI.To ensure that
all necessary testing is carried out
VII.To approve
specifications, sampling instructions, test methods and Quality Control
procedures.
VIII.To approve
and monitor any contract analysis.
Training is exactly what I need. I want to learn something new and improve my knowledge in my work. Thank you for your excellent post.
ReplyDeleteDaniela Camara.
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