Preparing for FDA Inspections in a Changing Regulatory Environment

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

Subscribe Newsletter

Main
Preparing for FDA Inspections in a Changing Regulatory Environment

Preparing for FDA Inspections in a Changing Regulatory Environment

| |

Instructor : Nancy Duarte-Lonnroth

Product Id : 600271

Overview: Ready for Inspection by Hamburg's FDA? Under Commissioner Hamburg's new enforcement policy, FDA has issued more warning letters more quickly than it has in years.

In some cases, the agency has even skipped warnings and gone straight from inspectional observations to injunctions and seizures. Clearly, the stakes will be higher at your next inspection. The question is: What steps should you take now to be ready for it?

The key to effective management of regulatory inspections is effective preparation. Being well organized and confident during the inspection means that your firm gives it's best possible performance which in turn gives the regulatory inspector the clear message that you know your business thoroughly. In this webinar, you will learn the key principles of the preparation of staff that will be expected to face the inspector(s).

This webinar was developed to help participants to determine what actions are needed to build a robust system for handling regulatory inspections.

Areas Covered in the Session:

Current trends
Staff Training and Preparation
Key steps to becoming inspection ready
Facing the inspector - Competent, Confident, Credible, Knowledgeable
Managing the inspection process

Use of high level presentations
Likely targets
Know and respect the inspector's techniques
Behaviors to encourage
Behaviors to avoid

Who Will Benefit:Recommended for compliance, legal, management, quality, regulatory, and technical personnel who directly interface with the FDA during inspections. The employees who will benefit include:

Regulatory Unit
QA Unit
Manufacturing
Validation
Consultants
Quality system auditors

Nancy, is the Director of Quality & Regulatory Affairs, Healthcare responsible for global coordination of Celestica's Healthcare Quality, Regulatory and FDA compliance. Nancy is Quality and Regulatory expert with fifteen years experience in regulatory affairs, quality systems, compliance, clinical quality, validation, auditing, quality control, data management systems, post market surveillance, supplier management and regulatory compliance in the areas of bio/pharmaceuticals, medical devices and combination products. Nancy has contributed to the success of both venture and public companies, establishing a track record of successfully achieving timely global regulatory approvals, initiating and effectively managing preclinical and clinical investigations and developing and maintaining effective and compliant quality systems in various healthcare sectors.

Related Webinars:

Effective & Essential CAPA process to avoid FDA 483