FDA Inspection Primer - Comprehensive Training Course Package (5 Courses)

Are you sure you're prepared for an FDA inspection in the new future? Do you think your personnel have received enough training to properly get through an FDA inspection?

To help FDA regulated companies prepare for agency inspections, we have created a comprehensive training webinar recording CD package covering areas such as the ground rules for handling and FDA inspection; what to expect during an inspection; tough cGMP inspections; the FDA’s new Part 11 inspection program; and responding to FDA Form 483s and warning letters.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

• Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules
• What to Expect During an FDA Inspection, and How to Handle It
• Conduct of the Tougher U.S. FDA cGMP Inspection
• Understanding and Preparing for FDA's New Part 11 Inspection Program
• Responding to FDA Form 483s and Warning Letters

Who will benefit?

These webinar recording CDs will be beneficial to the following:

All levels of Management for all departments; QA/QC/Compliance/Regulatory Affairs; Information Technology/Marketing & Sales; Engineering/Technical Services/Validation; Consultants; and Operations and Manufacturing.

Webinars included in the Package:

Surviving an FDA Inspection: Understand the Do’s and Don’ts and the Ground Rules (Duration: 60 minutes)

This webinar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection if you are a device or a pharmaceutical or biologics manufacturer.

Areas Covered in the Webinar:

• Why inspections are conducted and by what statutory authority?
• The emphasis on systems-based inspections…and the IOM and other crucial FDA reference documents.
• What is subject to FDA purview and what's off-limits?
• Understand and apply the do's and don'ts and comprehend that preparation is the key to success.
• What are the prohibited "Acts" and the enforcement categories that you need to deal with.
• What you need to know and do to prepare for, during and even after the inspection…and why your inspection response team is key?
• The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel.
• How to respond to findings and facilitating the documentation and remediation process…and reaching final closure?

About the Instructor:

David R. Dills, is Senior Consultant with PAREXEL Consulting. Prior to joining the consultancy, Mr. Dills provided independent consulting on technical and regulatory compliance to pharmaceutical, Class I, II, and III, medical device, and biotechnology companies with an emphasis on establishing sustainable compliance and validation environments.

What to Expect During an FDA Inspection, and How to Handle It (60 minutes)

This webinar discusses how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

Areas Covered in the Webinar:

• How to prepare for an FDA inspection.
• Development and contents of an SOP for FDA inspection.
• Personnel training before inspection.
• How to behave during an inspection.
• Limitations of scope of inspection.
• Response to investigation findings.
• FDA guidance documents used by their inspectors.

About the Instructor:

Jeff Kasoff , RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields.

Conduct of the Tougher U.S. FDA cGMP Inspection (95 minutes)

This webinar discusses how the on-site CGMP (Current Good Manufacturing Practices) compliance audit is changing and how a new tougher CGMP audit is being conducted by investigators based on new regulatory climate.

Areas Covered in the Webinar:

• The changing regulatory climate.
• Avoid complacency from past "good" FDA audits.
• Initial contacts and management team meeting.
• The tour and systems audit.
• Drilling down.
• Documentation / records issues.
• Damage control.

About the Instructor:

John E. Lincoln is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o Fortune 100, in the U.S. , Mexico , Canada , France , Germany , Sweden , China and Taiwan .

Understanding and Preparing for FDA's New Part 11 Inspection Program (93 minutes)

This Part 11 Inspection training answers all questions related to the new part 11 inspection program by FDA and FDA expectation of implementing part 11 requirements.

Areas Covered in the Webinar:

• FDA inspections: Preparation, conducts, follow up.
• Scope of the new Part 11 program: time frame, expected outcome.
• Criteria for selection of target companies.
• What will inspectors be looking for.
• How to prepare your company for the upcoming inspections.
• Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations.
• How to fill gaps short term.
• Developing a program for long term.
• Creating the right documentation to satisfy the inspectors.
• Most likely next steps after the inspection program.

About the Instructor:

Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories.

Responding to FDA Form 483s and Warning Letters (60 minutes)

This training on responding to FDA Form 483s and Warning Letters presents methods for reviewing, evaluating, and writing responses to FDA Form 483s and Warning Letters.

Areas Covered in the Webinar:

• What is an FDA Form 483?
• What is a Warning Letter?
• How to develop a company response?
• How to write a company response?
• Public access to FDA Form 483 and Warning Letter information.

About the Instructor:

Martha M. Bennett, RAC, provides a variety of regulatory affairs and quality system (GxP) consulting services to FDA regulated companies worldwide, covering foods, drugs and biologics, medical devices, and cosmetics. Based on almost forty years of experience within and outside of FDA, Martha assists companies with compliance, product development and approval, and post-marketing issues.

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