If you set out to hire two experts – each with more than 10 years of experience in managing pharma suppliers and contractors – to help you design the perfect supplier quality management program, the costs would be in the thousands.
Now you can have their insights and advice, right in your office, for less than it would cost to hire them for an hour.
Together, William Reiss, senior manager, supplier QA agreements & global sample retention at Celgene, and Steven Sharf, president, GMP Concepts, have overseen hundreds of quality agreements. And in this 3-hour DVD seminar, these two veterans will take you through all the issues you’ll need to consider when you negotiate or review a quality agreement from start to finish, such as:
· What can you realistically expect regarding change control?
· What role should lawyers play in preparing agreements?
· What allowances can you make for small companies?
· What are some workable penalties for noncompliance?
· What are reasonable audit requirements?
· What deficiencies can be offset by acceptance testing?
· And dozens more…
This FDAnews Insight Series Seminar includes the three-hour recorded seminar, an executive overview of the topic and all the relevant regulatory references — and you don’t even have to leave your desk to attend. Just pop the disk into your DVD drive and you’re ready to go.
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