Training  >  FDA Regulatory Training

FDA Regulatory Training for Product Safety, Quality, and Efficacy

FDA training is necessary to remain compliant. It makes employees keep abreast of the current regulations and guidance and how to adhere to them. The FDA training program includes various subjects — from conducting inspections to responding to 483s or warning letters.

FDA training
FDA training

Introduction to Food and Drug Administration (FDA)

Food and Drug Administration (FDA) is the U.S. Federal agency that protects the public health by regulating a range of products, including food, pharmaceutical drugs, cosmetics, dietary supplements, medical devices, vaccines, electromagnetic radiation emitting devices (ERED), blood transfusions, and veterinary products.

Additionally, FDA is also responsible for regulating the manufacturing and selling of tobacco products. Non-compliance to FDA regulations results in penalties on a company for the regulatory violations that affect customer confidence in its safety and efficacy.

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Objectives of FDA Training

FDA training helps create awareness about the regulatory requirements. The FDA regulatory training also prepares employees to handle any situation that has the potential for risk. FDA-regulated industries are challenged with numerous regulations and FDA training for compliance is essential to:

  • Ensure that the company adheres to the industry guidelines and that the products do not pose any risk to the consumer or public
  • Understand current industry trends and requirements
  • Understand regulatory compliance and different approaches to compliance
  • Prepare for regulatory initiatives, challenges, and compliance
  • Gain insight into the benefits of QMS
FDA training objectives
regulatory training focus areas

FDA Training materials, to whom is it required, and focus areas?

FDA developed various training materials, including webinars, courses, and other materials to better understand FDA’s regulation of product safety, quality and efficacy.

The regulatory training helps regulators, foreign and domestic industry, medical professionals, academics and others to remain FDA compliant.

Some of the focus areas include:

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FDA Regulatory Training requirements

The requirements for regulatory training focused on GMP are divided into two aspects — types of employees who need to be trained and the components of the training program.

Types of employees who need regulatory training include:

  • Employees across various departments such as manufacturing, warehousing, or packaging
  • Supervisors involved in the development, manufacturing, or drug storage to ensure safety and quality
  • Personnel who are qualified to manufacture and supervise the process

FDA is very specific about who is trained and what they are trained for. Some of the guidelines for the FDA training include:

  • Employees who are part of production or drug storage must have relevant experience and training
  • The training must be for the exact process along with detailed information on the CFR requirement and the procedures associated with their role
  • All the training related information must happen at regular intervals and must be delivered by a qualified personnel
  • Employees must be trained for various corporate training requirements such as orientation, quality systems, safety, job-specific training, and re-training information
regulatory training requirements

The FDA training program is overseen by the senior management. To meet FDA requirements, manufacturers must prepare and conduct detailed training programs that will sustain the quality of the products and the safety of the employees.

The FDA regulatory training plan must include all the training information, such as CSR regulation and other job function-specific procedures. An FDA inspection includes an evaluation of the training documents. FDA regulatory training program will focus on:

  • A clear evaluation of the organization’s training needs, including training schedules, and all relevant information for every function
  • Training delivery in the form of case studies and scenarios through qualified instructors
  • Evaluation to understand the effectiveness of the training in the form of test on the last day of training
  • Documents keeping to showcase all the training provided with other details such as the content of the training, results of the evaluation, and the date of the next training session
fda training - customer success

Customer Success

Winning Story of Two Businesses Using the CQ Training and Document Management Solution to Improve Their Quality Management Process

fda training - customer success
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ComplianceQuest Solutions For FDA Training

Following the FDA software validation guidelines, CQ assists customers throughout the process of validating the entire solution. Once the solution is installed, CQ will help with the following:

Installation Qualification
Installation Qualification (IQ):

Ensures that the solution is installed correctly.

Operational Qualification
Operational Qualification (OQ):

Establishes documented evidence that operating characteristics perform within the limits and specifications defined for the system.

Performance Qualification
Performance Qualification (PQ):

Allows conversion of the OQ to PQ to establish documented evidence of consistent performance as defined for the system.

Functional Requirement Specifications
Functional Requirement Specifications (FRS):

Provides design and test traceability.

ComplianceQuest also supports 21 CFR Part 11 FDA compliance requirements for life sciences organizations in health-care, pharmaceutical, life-science, biotechnology, medical- manufacturing, medical devices, and other FDA-regulated industries. This also allows companies to adopt a ‘paperless’ system of record keeping. Our solutions include:

Electronic Signature:

As required by 21 CFR Part 11, ComplianceQuest ensures that the user has signed onto the system and automatically secures the authenticated user’s electronic signature. Every time a transaction is processed, signed authentication is mandated making it a secure process similar to a paper-based system.

Audit Trail:

ComplianceQuest system has Audit Trail that securely and automatically posts all field changes to a separate database, including the details of the user who made the change, date and time. This stored audit trail information can be queried and accessed at the time of any regulatory audit.

CQ Works Great and is a Pleasure to Use

We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.

Helen Cary,
Document Control Specialist

lin engineering
lin engineering

Quality-centric Companies Rely on CQ QMS

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Remain compliant with CQ's FDA training solutions to keep abreast of product safety, quality, efficacy and understand current industry trends and requirements

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Frequently Asked Questions

  • FDA 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to that of the paper records. It is applicable to all in the life sciences industries including Medical Devices manufacturers, drug makers, biologics developers, and biotech companies. 21 CFR Part 11 stipulates the guidelines and rules for storage, copying, access & permissions, audit logs and tracking.

  • Part 11 applies to drug makers, biotech companies, medical device manufacturers, CROs, biologics developers, and other FDA-regulated industries, with some specific exceptions. The code is for implementing controls such as audits, audit trails, electronic signatures, system validations, and documentation for software and systems.

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