Are You Ready for Joint Inspections?
How to Survive When the FDA Teams Up With International Regulators
According to the head of the inspection sector at the European Medicines Agency (EMEA), joint inspections with the FDA are scheduled to start in the next few weeks. That’s an unprecedented challenge for drugmakers.
The problem isn’t just different languages (though you will need to have translators on hand). It’s also the widely differing expectations: The FDA, for example, takes an enforcement-oriented approach while EMEA takes more of a consulting role. That means you’ll have one set of inspectors scrutinizing your labs and plants while the other inspectors comb through your records.
What best practices will satisfy both? And what smart steps can you take now so joint inspections don’t expose you to twice the risk, cost and headaches?
Find out in the audio CD/Transcript , Are You Ready for Joint Inspections?
Anticipate what it takes to satisfy both the FDA and international inspectors.
From years of experience with the separate regulatory guidelines they follow, FDA and EMEA inspectors couldn’t be more different! But during this 90-minute audio CD/Transcript, former FDA inspection official Peter D. Smith draws on decades of international experience to help you reduce the burden — and risk — of preparing for joint inspections by explaining both the common ground and the differing requirements before officials arrive at your door.
Order for your entire team to listen and prepare for joint inspections with practical guidance on:
- How to prepare for joint inspections — don’t do twice the preparation yet — attend this audioconference and find out precisely what you’ll need to do
- What each agency will be looking for — including what manuals and regulations they’ll be using to evaluate your operations
- Which cGMPs you should use and other best practices to follow to make sure all your operations stand up to twice the scrutiny
- What “small details” make a big difference — such as having the right translators and enough staff on hand
- Specific inspection methodologies — who will spend time in your labs and plants, who will want to see your records — and what they’re each looking for
- How to respond to concerns — including when you should and should not submit a joint response
- Lessons learned — practical insights from real-world examples of early joint inspections
- Trends in harmonization between the FDA and EMEA
Plus, you'll get an opportunity to hear your colleagues ask the toughest questions during the Q&A session.
Order now and benefit from the practical know-how that you’ll be able to use as you prepare for a joint inspection.
Peter has primary expertise in GMP for active pharmaceutical ingredients and non-sterile dosage forms, management of preapproval inspections, management of foreign inspections, GMP quality systems and FDA regulatory issues. He has experience in antibiotics, radiopharmaceuticals, parenterals, nonclinical GLP laboratory studies and GCP compliance. He works with biologics and pharmaceutical client companies to achieve site facility compliance and prepare for successful regulatory inspection outcomes. In addition, Peter conducts GMP audits and assessments. He is a highly experienced public speaker and trainer in GMP and FDA inspections readiness topics.
This audio CD/Transcript is a must for outsourcing contractors as well as personnel in drug and device companies, including:
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