Why is FDA at my facility, and what do I do during an inspection 2017

 Course "Why is FDA at my facility, and what do I do during an inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

Who will benefit:

Industries

FDA regulated Industries

Medical Device

Pharmaceuticals

Clinical

Dietary Supplements

Food

Nutraceutical

Healthcare IT

Technical Services

Validation

Engineering

Small Business Owners

Departments

Top and Middle Management

Quality Assurance/Management

Compliance Management

Manufacturing

Laboratory

Regulatory Affairs

Information Technology

Marketing & Sales

Operations

Research & Development

Types of facilities:

Manufacturing facilities

Contract manufacturing facilities

Distributors

Packaging, Labeling

API Suppliers

Laboratories

Importers

Documentation Management

Agenda:

Lecture 1:

How a firm should prepare for an FDA inspection

Lecture 2:

Ways to train employees in view of the inspection

Lecture 3:

How to ensure that required documentation is in place

Lecture 4:

How to interact with the investigator-DO's and DON'T's

Lecture 5:

What companies should do when the inspection ends

Lecture 6:

How to reply to 483's and warning letters

Lecture 7:

Legal implications of non-compliance

Lecture 8:

Post inspection actions

Day 2 Schedule

Lecture 1:

Why inspections are conducted and by what statutory authority

Lecture 2:

The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents

Lecture 3:

What is subject to FDA purview and what's off-limits

Lecture 4:

Understand and apply the do's and don'ts and comprehend that preparation is the key to success

Lecture 5:

What are the prohibited "Acts" and the enforcement categories that you need to deal with

Lecture 6:

What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key

Lecture 7:

The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel

Lecture 8:

How to respond to findings and facilitating the documentation and remediation process...and reaching final closure

Lecture 9:

Define clear responsibilities, roles and goals for personnel involved in SOP development

Speaker:

David R. Dills,

Regulatory Affairs & Compliance Consultant.

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, post marketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to post marketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.