J
jpb0205
First post so hello all and hope this is in the correct place
My current company (pharmaceuticals) closed down and then re-opened as a much smaller organisation less than a year later. At the time of the closure, there was no anticipation of the comeback and a lot of documentation was destroyed, including staff training records. Some staff previously employed came back and now do not have their training records. We inserted an explanatory statement into each training record, that they were previously trained and are qualified by previous experience and qualification which the regulatory body (GMP inspection) found acceptable but at a recent audit, this was heavily criticised and the auditor expected much more but did not make it clear what they expected to see.
Can anyone help with what they would expect to see and/or provide any guidance on how to make the best of this pretty bad situation?
Thanks very much for any assistance.
My current company (pharmaceuticals) closed down and then re-opened as a much smaller organisation less than a year later. At the time of the closure, there was no anticipation of the comeback and a lot of documentation was destroyed, including staff training records. Some staff previously employed came back and now do not have their training records. We inserted an explanatory statement into each training record, that they were previously trained and are qualified by previous experience and qualification which the regulatory body (GMP inspection) found acceptable but at a recent audit, this was heavily criticised and the auditor expected much more but did not make it clear what they expected to see.
Can anyone help with what they would expect to see and/or provide any guidance on how to make the best of this pretty bad situation?
Thanks very much for any assistance.