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aq49
aq49
@aq49
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Joined: Sep 8, 2024
Last seen: Mar 16, 2025
Topics: 0 / Replies: 51
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RE: Different Organizations for Different Industries

It’s really interesting to see how different organizational structures can benefit various industries and even specific types of companies within thos...

4 months ago
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RE: Ghantt Chart vs. Network Diagram vs. Other?

These are all great perspectives and I agree that both Gantt charts and network diagrams serve important, complementary roles in project planning and ...

4 months ago
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RE: Device Companies Org Development

These are all insightful points and I agree that organizational change is about more than just structural adjustments, it’s also about fostering adapt...

4 months ago
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RE: Getting Everyone's Input in Risk Management Meetings

These are good suggestions, I really like the idea of using tools like Trello or Miro for virtual collaboration, especially when in-person meetings ar...

4 months ago
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RE: Risk Analysis Experience

I really enjoyed reading everyone’s experiences—it’s fascinating to see how CAPAs and risk management play out in different settings. I don’t have aud...

4 months ago
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RE: Distinguishing Between Hazards and Hazardous Situations in Risk Evaluation

I completely agree that distinguishing between hazards and hazardous situations is key to effective risk management. Evaluating hazards helps us ident...

4 months ago
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RE: Understanding Design Controls and Documentation in Medical Device Development

These are good points about the importance of Design Controls and documentation! I like how the connections between the design Input, output, verifica...

4 months ago
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RE: Risk Management in Verification & Validation

Thats a good explanation of how risk management integrates with verification and validation, and I think the emphasis on iterative risk evaluations, p...

4 months ago
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RE: Impact of customer feedback on design inputs

These are good points about how customer feedback is handled in the design input process, and I like the emphasis on breaking down vague feedback into...

4 months ago
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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...

5 months 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. ...

5 months 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...

5 months 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 months 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 months 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 months ago
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