FDA Inspection Training Description
This FDA inspection training is very productive. After the completion of this training course, every participant will learn and adopt the best ways to set the regulatory inspection. It can make sure that the inspection will flow smoothly all along the duration of the course. It teaches the participants ways to speak to the instructors to perform the right audit!
The reason and scope of the Regulatory inspection is a preferred activity that can show you and make you understand what your company does to operate. The company follows proper CFR needs and requirements that help it to maintain the state of compliance. The process of training can be the secret key to communicating how the popular systems ensure this state of control.
On most occasions, the use of a new regulatory investigator is a tough task for some people or agencies. You can take the right advantages by taking the course that we offer. The seminar brings you the right knowledge by bringing you the right protocol to set up the room for the inspection, especially the ‘war’ room that can help and support the inspection process! The right preparation for this normalizes and shortens the disorder and stress factors that you may know during the inspections.
Regulatory surveillance or inspections are a time to show high-level compliance that your firm has the authority to do the regulations. It also takes care of the safety of the customers and the quality. The most prominent purpose of the regulatory inspection is to make sure that your facility is in the right agreement with FDA Regulations. The professionals engaged in the investigation need to know that the product was produced following the right procedures. The regulation is also very effective in setting up the right manufacturing practice that is often prepared and enforced by FDA. The aim of this regulatory inspection is to take care of the whole inspection and generate a satisfactory report.
The inspection the managers plan ought to accommodate, Response to the appearance of the agents, Guidance of the auditors' exercises, Procedure for working with the specialists, and Documentation of the review. The management plan or SOP ought to be explained to every one of the plans that you will follow during an examination. Staff preparation is a vital variable that ought to be checked out preceding any review. Instruct faculty about the assessment cycle so they can be ready. Train people to communicate with FDA agents. Check that preparation has been accommodated to the workforce in their present place of employment capabilities, and that supporting records are on the document. The objective is to limit the chance of wrong responses given to the investigators, or giving a lot of data. Have a rundown of what to do and what not to do while addressing the investigators too.
Training Agenda Day 1
•Module 1: 10:00am – 11:30am
BREAK 11:30am ET-12:00pm ET
•Module 2: 12:00pm ET-1:00pm ET
•Preparing for FDA audits
•Do’s and Don’ts
LUNCH 1:00pm ET-1:30pmET
•Module 3: 1:30pm-2:15pm
•FDA Game Show
•Module 4: 2:30-3:00pm
•How to do mock inspections
Agenda Day 2
•Module 1: 10:00am – 11:00am
•How to respond
•Module 2: 11:15am-12:15pm
•CAPA and the 483
•Module 3: 1:15pm-2:15pm
•Real life inspection scenarios
•Module 4: 2:30-3:00pm
Objectives of Learning:
After completing this course in FDA inspection training, the trainees will be able to understand!
▪ Acquire Pre-planning and groundwork actions
▪ Distinguish what you should do when the agent arrives
▪ Know what credentials to have ready and on hand
▪ Grow assignments and errands for the review
▪ Be aware of Do's and Don'ts
Who Will Get the Real Benefit?
This all-inclusive course aims at reaching individuals who have direct or indirect participation in FDA inspections. These functions include among others:
▪ Professionals for Technical Services
▪ Laboratory Operation professionals
▪ Plant Managers
▪ Auditing professionals
▪ Engineering aspirants
▪ Quality Assurance/Quality Control managers or professionals
▪ Documentation Managers
▪ Regulatory Affairs
▪ Executive Management
Research and Development
Reasons that make you attend the FDA Inspection Training
No one should get dreaded for an FDA inspection if you are sufficiently ready. These inspections have exposed some inclinations in recent years. The FDA is all set to take a rougher and harder stand on Quality Management Systems and use a risk-based approach. The FA inspectors typically review at least two (2) systems in depth. Here, quality assurance has been the top-rated concern in recent years.
The FDA does not suppose your ability to be faultless. The professionals expect all businesses to have some specific issues. The FDA tends to opinion companies that regulate these matters to have a great average of quality. This seminar will help you use the FDA inspection as a learning tool, not as a negative or adversarial experience.
Principal/Owner, ASA Training & Quality Consulting, LLC
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility.