FDA Training

CQ Training Management – FDA training to remain compliant

What does FDA training stand for?

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.

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.

Objectives of FDA Training

Regulatory compliance training helps create awareness about the regulatory requirements. The 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

What are the focus areas in regulatory training?

FDA developed various training materials, including webinars, courses, and other materials to better understand FDA’s regulation of product safety, quality and efficacy. The training helps regulators, foreign and domestic industry, medical professionals, academics and others to remain FDA compliant. Some of the focus areas include –

Good manufacturing practices (GMP)
FDA enforcement actions
Warning Letters
Quality and safety standards
CAPA
Data management and documentation
Verification and validation
Packaging and labeling

What are the requirements for regulatory training?

The requirements for FDA 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

The FDA training program is overseen by the senior management. The training plan must include all the training information, such as CSR regulation and other job function-specific procedures. 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. 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

Requirements for FDA regulatory training

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 (IQ): Ensures that the solution is installed correctly.
Operational Qualification (OQ): Establishes documented evidence that operating characteristics perform within the limits and specifications defined for the system.
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 (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

ComplianceQuest automatically secures and binds the authenticated user’s electronic signature. It ensures that the user has signed onto the system and exposed their signature via the forced authentication process, as required by 21 CFR Part 11. Authentication is required each time a transaction is processed, equivalent to a paper form that an individual would have signed.

Audit Trail

ComplianceQuest securely and automatically posts all field changes to a separate database. The Audit Trail includes the field’s old value, new value, name of the user who made the change, and date and time. ComplianceQuest stores the audit trail information, allows for the information to be queried and presents the information to support a regulatory audit.

Frequently Asked Questions

What is FDA 21 CFR Part 11?

21 CFR Part 11 is the FDA guideline that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to that of the paper records. Part 11, as it is commonly known, was introduced in 1997 and applies to FDA-governed industries that choose to store their primary, authoritative records electronically. It stipulates the guidelines and rules for storage, copying, access & permissions, audit logs & tracking. It also identifies version control of the electronic records and the application of electronic signatures to them.

Who does 21 CFR part 11 apply to?

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.