FDA Regulatory Inspection and Audit Training: Pack of 6 Training Courses

You receive a written notice from the FDA stating that your facility will be inspected. Shortly thereafter, an FDA investigator arrives at your door for inspection. Are you ready?

Refusals, denials, or refusal to permit entry of inspection allows the FDA to deem a product to be adulterated. If the product is deemed as adulterated, the firm is prohibited from introducing an adulterated product into interstate commerce. Legal actions may include civil money penalties, seizure, injunction and/or prosecution. Administrative remedies include import detention and / or recall. It's better to prevent such problems than face costly consequences.

Common deficiencies identified in the FDA inspections include:

• Non-compliance with CGMPs
• Not knowing answers to investigator's questions
• Incomplete documentation
• Unpreparedness for the inspection

Buy this training kit to equip yourself and your staff with the knowledge required to face inspections. It will detail what you should do to survive an FDA inspection with the least possible pain.

All Modules:

Module 1: Regulatory Inspections and Quality Audits
Module 2: Regulatory Inspections - How to prepare for a visit from an FDA Auditor
Module 3: Surviving an FDA Sponsor Inspection - Training for Success
Module 4: FDA Establishment Inspections - What to Expect?
Module 5: How to Prepare for an FDA Inspection?
Module 6: FDA Inspection Readiness

Part 1 : Regulatory Inspections and Quality Audits
Instructor: Martin Lessem

Areas Covered in the Webinar:

• FDA Audits/Inspections
• Other Health Authority Audits
• Pre-Inspection/Audit Preparation
• Internal Roles during an Inspection/Audit
• Dealing with the aftermath of Health Authority Inspections
• The 483 Form
• Internal Audit results and how to handle them
• Reporting requirements for internal audits

Part 2 : Regulatory Inspections - How to prepare for a visit from an FDA Auditor
Instructor: Joy McElroy

Areas Covered in the Webinar:

• The purpose and scope of FDA audits
• FDA forms 482 and 483
• What exactly a QSIT audit entails and how to pass it
• How to Develop an audit preparedness plan that you can use to execute the audit
• Understand what the FDA will look for at the conclusion of your audit
• Do's and Don'ts on how to address FDA representatives
• Do's and Don'ts for your audit team
• Tips and tricks to ensure smooth audit experience

Part 3 : Surviving an FDA Sponsor Inspection - Training for Success
Instructor: Stephen Schwartz

Areas Covered in the Webinar:

• FDA inspectional procedures; What sponsor staff are audit targets and how FDA inspections are performed
• Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement
• FDA sponsor inspection objectives and perspectives
• Typical and common FDA questions and how not to respond
• The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations
• Audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection

Part 4 : FDA Establishment Inspections - What to Expect?
Instructor: Charles H Paul

Areas Covered in the Webinar:

• The inspection process – what to expect
• Importance of truthfulness
• Importance of knowledgeability and confidence
• FDA Tricks to elicit information
• Arguing and challenging
• Behavior during the inspection
• Importance and role of documentation
• Effective communication skills
• Being deceptive
• Opinion versus fact
• Phrases never to say
• Handling adverse findings during the inspection

Part 5 : How to Prepare for an FDA Inspection?
Instructor: Loren Gelber

Areas Covered in the Webinar:

• General Information about FDA Inspections
• Inspection Classification
• Planning for Inspections
• Self Audit Process
• Practice or Mock Inspections
• Corrections
• Responding to inspectional observations
• FDA Warning Letters and 483s (What not to do)

Part 6 : FDA Inspection Readiness
Instructor: Susanne Manz

Areas Covered in the Webinar:

• FDA Inspection approach
• Inspection preparedness strategy and planning
• Key roles during an inspection
• SME (Subject Matter Expert) training
• Checklists for preparing
• How to manage an inspection
• Common mistakes to avoid
• How to respond to inspection observations

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