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Establishing an Effective Document Control System
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This is a recording of Berkshire Sterile Manufacturing's webinar that aired on Thursday, December 10th at 11AM EST.
Document Control is one of the most critical aspects to meeting FDA compliance requirements. Last year, many FDA 483 violations were related to Records and Reports (23%; 21 CFR Part 11 Sub-part J).
However, it is easy to get lost when establishing a document control system or implementing an electronic document control system. How do you develop a process to effectively manage the creation, review, modification, issuance, distribution, and accessibility of all controlled documents?
This webinar describes what a Document Control System is, why it's needed, what the requirements are for FDA regulated facilities, and how Berkshire Sterile Manufacturing (BSM) has established its own effective Document Control System.
Document Control is one of the most critical aspects to meeting FDA compliance requirements. Last year, many FDA 483 violations were related to Records and Reports (23%; 21 CFR Part 11 Sub-part J).
However, it is easy to get lost when establishing a document control system or implementing an electronic document control system. How do you develop a process to effectively manage the creation, review, modification, issuance, distribution, and accessibility of all controlled documents?
This webinar describes what a Document Control System is, why it's needed, what the requirements are for FDA regulated facilities, and how Berkshire Sterile Manufacturing (BSM) has established its own effective Document Control System.
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