Effective Date (of Documents) issue outlined in 21 CFR Part 820.4

Ronen E

Problem Solver
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#11
Hi all,

I totally agree with your hints...

I only would do training after the work instruction was approved.

Regarding the effective date - for me this is the point in time when a change of the work instruction becomes effective and is obligatory for the manufacturing department...
Considering these thoughts - from my point of view it not possible to have the approval date and the effective date on the same day...only in the case - if the training is finished on the day of approval...

Am I right with my guesses? :cfingers:

BR
Aphel
It's true if the document covers a daily / continuous activity.

If you update your management review procedure, and it requires application once every 12 months, then in most cases you will have plenty of time following approval and before actual implementation...

By the way, you can easily solve the conflict by introducing a transition period clause. However, you will then have to properly manage it - for example, require that workers record the version to which they have performed a task. There are many possible solutions, be creative. Only you know what is practical in your situation and what are the limitations.

Cheers,
Ronen.
 
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#12
Hi all,

I totally agree with your hints...

I only would do training after the work instruction was approved.

Regarding the effective date - for me this is the point in time when a change of the work instruction becomes effective and is obligatory for the manufacturing department...
Considering these thoughts - from my point of view it not possible to have the approval date and the effective date on the same day...only in the case - if the training is finished on the day of approval...

Am I right with my guesses? :cfingers:

BR
Aphel
Aphel,

I completely agree. I have seen companies where approval meant that the subject matter experts approved the document contentwise, while for the document to become effective doc control had to officially release it whatever their system was. How ever even then they often called this last step also "approval"...
 
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