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aq49
@aq49
Eminent Member
Joined: Sep 8, 2024
Last seen: Nov 5, 2024
Topics: 0 / Replies: 27
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RE: Auditor's view of DHF / DHR

It’s great to hear about everyone's audit experiences and insights on DHF, DMR, and DHR distinctions. I haven’t personally participated in an audit, b...

4 days ago
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RE: Validation's Role in Quality Product Development: Insights and Challenges?

These insights highlight how vital validation is for ensuring that a product not only meets regulatory requirements but also truly serves user needs. ...

4 days ago
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RE: The Defines of Design Controls

Great points on the role of risk management and documentation within design controls. Embedding risk assessments like FMEA into the design process def...

4 days ago
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RE: Multi center xlinical teials and difficulties faced

Multi-center trials definitely bring unique challenges, especially around maintaining consistency across sites. I agree that clear communication and s...

5 days ago
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RE: Patient safety and data integrity during clinical trials

Patient safety and data integrity are at the heart of clinical trials, and guidelines like ICH and GCP provide a framework to ensure both. These stand...

5 days ago
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RE: Challenges faced in patient recruitment, how can CROs and CRAs address them?

Patient recruitment is a big hurdle in clinical trials, often causing delays and impacting study timelines. CRAs and CROs tackle this by using diverse...

5 days ago
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RE: How Sales and Marketing Works

These replies are great, and i’d also add that alignment between sales and marketing is key - when both teams collaborate effectively, the customer ex...

3 weeks ago
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RE: marketing strategies and technology

These are all great points, and I would add that medical device marketing also needs to focus on transparency and education. With technology evolving ...

3 weeks ago
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RE: Company Mission Statement

If I were to create a company, it would focus on developing sustainable healthcare technologies, specifically affordable diagnostic devices for unders...

3 weeks ago
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RE: S or C Corperation

Both structures definitely have their pros and cons, and I think the choice really comes down to the business’s growth plans and funding needs. For sm...

4 weeks ago
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RE: For New Business Builders

These are all great points, and I’d also add that building strong relationships with customers, vendors, and partners plays a key role in long-term su...

4 weeks ago
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RE: LLP vs LLC

These are great points. I’d just add that LLCs are usually the go-to for entrepreneurs because of their simplicity and flexibility, especially for ow...

4 weeks ago
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RE: The Quality Unit

Regulatory Affairs is an interesting field, and while I haven’t worked in it myself, I know that it plays a vital role in bridging the gap between com...

1 month ago
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RE: QA/QC Audits

I agree that audits, both internal and external, play a crucial role in ensuring that QA and QC follow proper protocols. It"s interesting how QA is ob...

1 month ago
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RE: FDA Advisory Panel Members with QC/QA Background

These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products....

1 month ago
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