GMP Compliance Basis Blog

I had a brief conversation with some folks from LS Planning last week at the ISPE Meeting…

I asked them how they convinced their clients buy into the idea of strategic planning…

They indicated that there was a cost associated with planning, and that it was more cost effective than not planning…

The “Cost of Acting versus Re-acting”…

Some people might want to perform a cost comparison to prove this point…

I think it’s more important that you just believe it…

Invite them to the ISPE Annual Meeting…

for the Wednesday session…

The most productive discussion will not focus so much on what each wants from the other… for instance, what clients want from their consultants…or what do consultants want from personnel on the operations side.

The more interesting discussion (and probably most productive for all concerned) will be about how to communicate to the other party…what you need, what isn’t happening, what is missing…in such a way that the other party listens, understands, and has a chance to move these issues forward.

The most interesting sessions

Our Blog of the Week…

ISPE Annual Meeting 2006 Blog

Check it out…

Practical Applications

Joint ISPE/ PDA Seminar addressing Q8 & Q9 Guidances…

Benefits of attending:

• Become aware of the process and interactions in the development of the Q8 and Q9 Guidances
• Recognize the benefits of Q8 and Q9 implementation
• Hear the concepts surrounding regulatory flexibility based on relevant scientific knowledge from leading subject matter experts
• Learn how the concept of design space impacts regulatory assessment and approval of a product
• Apply the concepts and principles contained in the Q8/Q9 Guidance documents to your company’s manufacturing and R&D practices
• Network with your peers to learn how the Guidances are being implemented by regulators and industry in the three ICH regions
• Determine future needs for a long term vision related to Q8/Q9 implementation
• Learn how to assure development of a quality product over the product life cycle from pre-clinical to post-marketing

Learning Objectives

At the completion of this Conference, participants will be able to:

• Explain the thinking that went into the development of the Guidances
• Apply the concepts and principles contained in the Q8/Q9 Guidance documents to their company’s manufacturing and R&D practices
• Identify challenges and mitigate risks associated with pharmaceutical manufacturing and development
• Differentiate regional obstacles to implementation

went to the ISPE Annual Meeting in Arizona…it’s been nearly a month already…

See you out there…

I’ll be blogging portions of the event…watch for posts…

ISPE 2005 Annual Meeting