IntenseDebate - Jim Pomager

4 years ago @ Pharmaceutical Online - Remote Auditing Best P... · 0 replies · +1 points

Here's the author's response, John...

John,

Thank you for the positive comments. You bring up a good point. First of all, I would assume that both parties have an executed NDA which prohibits the disclosure of information without prior authorization in writing. What does your quality agreement say? I can understand the CMO’s concern, but if the virtual tour is limited to the scope of your products that should help minimize those concerns. Additionally, I doubt that any video or picture taken during an audit of this type will ever be up for an Emmy Award! Given the current situation, attitudes will have to change to adapt. If the CMO is unwilling to accommodate your request, I am absolutely certain there are others that will. You are the customer, you issue the purchase orders, and you ultimately pay the bills!

Mark

4 years ago @ Pharmaceutical Online - When Should Formal Qua... · 0 replies · +1 points

Good catch, Jerry! The link to Kevin's QbD myths article has been added to the opening paragraph. Thanks...

4 years ago @ Pharmaceutical Online - FDA’s Top 5 Drug... · 0 replies · +1 points

Thanks for your comment, Prakash. Here is the link to Part 1: https://www.pharmaceuticalonline.com/doc/fda-anal...

4 years ago @ Pharmaceutical Online - How To Establish Sampl... · 0 replies · +1 points

Hello, Avraham. Thanks for bringing this issue to our attention. The correct Table 3 has been inserted.

4 years ago @ Pharmaceutical Online - How To Prepare For An ... · 0 replies · +1 points

Thanks for your comment, Robbie. Here's a response from the author:

"These are all great ideas, some of which I have used before. I really like the idea of using the ‘Post-It Notes’ coding system. The Management Representative should never be surprised under any circumstances!

Sounds like your organization is inspection ready!"

4 years ago @ Clinical Leader - CRO,... - India Making Way For S... · 0 replies · +1 points

Hello, Prashant,

The author asked me to post this reply: "The study does not appear to require CDSCO approval and is likely to fall under 'Biomedical and health research.' You may please proceed with submission of the study proposal to your ethics committee and if they are in doubt, they can formally write to CDSCO and seek clarification if it requires their approval as well.”

Jim Pomager
Executive Editor

5 years ago @ Pharmaceutical Online - Regulatory Expectation... · 0 replies · +1 points

Hi, Marina. Part 2 will be published on Apr. 19.

5 years ago @ Pharmaceutical Online - When To Use A Fishbone... · 0 replies · +1 points

Hi, Fabian. Here is the link to Part 3 of the series, which covers 5 Whys:
https://www.pharmaceuticalonline.com/doc/fault-tr...

5 years ago @ Clinical Leader - CRO,... - Should You Conduct You... · 0 replies · +1 points

The correct year is 2023 for both references. We have corrected the error in the first paragraph. Thanks for bringing this to our attention, and sorry for any confusion it may have caused.

5 years ago @ Pharmaceutical Online - Using Preliminary Haza... · 0 replies · +1 points

Thanks for pointing out the issue with Figure 3. It has been replaced with the proper image.

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