Hmm, this is a tricky one. I need to really think through the different options and how they relate to reducing liability. Process control, corrective action, design, validation - they all seem relevant, but I'll have to carefully consider which one is the most important factor.
Hmm, I'm not 100% sure about this one. The wording is a bit confusing. I'll need to re-read it a few times to make sure I understand what they're asking before answering.
Pearlie
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