FDA Training

Regulatory Requirements

• FDA 21 CFR Part 211.25 for pharmaceutical companies: All those responsible for the manufacturing, processing, packing, or holding of a drug product should be given training in current good manufacturing practices.
• FDA 21 CFR Part 820.25 for medical device manufacturers: Train personnel in identifying device defects, prevent defects through proper performance of their specific jobs, and empower personnel performing verification and validation activities to identify defects.
• ISO 9000 2000 for general manufacturers and other businesses: Train employees to ensure their work is of high quality and to assess the effectiveness of the training itself.
• ISO 13485 for medical device manufacturers: Train to ensure the accepted level of competence in carrying out their duties and ensure quality.

Terms you must know

• Abbreviated New Drug Application (ANDA): ‘Abbreviated’ drugs refer to Generic Drugs that do not require preclinical animal and human testing data to be included for approval. The application is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs for review and approval of generic drug products—only a bioequivalent needs to be provided.
• Active Ingredient: A component that enables the diagnosis, mitigation, treatment, cure, or prevention of a disease.
• Approval History: The approval history is a chronological record of all the FDA actions performed on a drug product with a particular FDA Application number (NDA). There are 50 kinds of approval actions involved, such as labeling changes, administrative changes, targeting a new patient population, and so on.
• Approval Letter: The FDA’s official communication allows the commercial marketing of a new drug.
• Biological Product: Products such as vaccines and blood and blood components that contain sugars, proteins, nucleic acids, or complex combinations of these substances, and living cells and tissues are called biologics.
• Chemical Type: A new drug formulation or a modified existing drug formulation is called Chemical Type.
• FDA Action Date: The date when an FDA regulatory action, such as an original or supplemental approval, was implemented.
• Marketing Status: This indicates how a drug product is sold in the United States, including:
• Prescription
• Over-the-counter
• Discontinued
• None - tentatively approved drug products
• Medication Guide (informing patients on the safe use of a drug product)
• New Molecular Entity (NME): An active ingredient with no active moiety, approved earlier under section 505 of the Federal Food, Drug, and Cosmetic Act, or previously marketed as a drug in the United States.
• Pharmaceutical Equivalents: The following three criteria decide if drug products are pharmaceutical equivalents:
• If they have the same active ingredient(s)
• Recommend the same dosage form and mode of administration
• Have identical strength or concentration
• Product Number: A product number is assigned to each drug product associated with an NDA (New Drug Application). If a drug product is available in multiple strengths, there are multiple product numbers.

These are a few of the relevant terms that employees in the life sciences industry must be aware of.

How to Identify Who Needs Training

Training must be provided to employees:

• When they are recruits
• In case of restructuring, change in processes/technologies, etc
• In case of a change in regulatory requirements needing new skills to ensure quality and performance
• After a periodic assessment that reveals skill gaps
• After a quality event or FDA warning letter/recall

Best Practices

Some of the best practices for imparting FDA training include:

1. Conduct a performance gap analysis to identify any shortfalls between the desired and the actual performance of the business.

2. Identify the root cause through root cause analysis to determine the true reason for the gap.

3. Run a needs analysis to identify the potential solutions to address the root cause effectively.

4. Recommend solutions, including training, especially when performance is a persistent issue. Some of the gaps for which training is a solution include:

• Skill or knowledge deficiency
• Regulatory updates needing new knowledge or skills
• Upskilling to adopt new technologies
• To improve performance standards
• To keep employees engaged and take ownership

5. Provide training using internal or external trainers who are qualified.

6. Monitor and track the effectiveness of the training programs for continuous improvement.

7. Define and document training programs to meet regulatory requirements.

CQ for Effective

ComplianceQuest is a cloud-based EQMS with a dedicated training module that facilitates training management for improved compliance. It enables the delivery of the training required for each individual with complete visibility throughout the knowledge acquisition process. It enables businesses to have a stable, reliable, and repeatable training management process, covering right from GxP guidelines to international standards to government regulations. It helps businesses manage all personnel, job functions, requirements by job functions, courses, and documents to be trained on.

It facilitates a culture of transformation by helping businesses maintain compliance and always be ‘Audit Ready’. Individualized and role-specific training can be designed and delivered with ease. Maintaining up-to-date training records and supporting online learning for the virtual environment is also made possible by this cloud-based solution.

How can training help companies become audit-ready?

A cloud-based solution such as ComplianceQuest’s training management software can provide a complete view of training compliance. The documents are connected to training programs and data can be easily retrieved from a centralized location. As a key regulatory requirement (e.g., ISO, FDA, OSHA) for industries such as life sciences, aerospace and defense, chemical, etc., when employees are continually trained based on need, they can demonstrate audit and inspection readiness. With ready and automated access to new content as it’s developed, the workforce is well-positioned to rapidly deal with new regulations.

How can role-specific, customized training be planned and delivered?

Business leaders must define training plans specific to particular job roles, titles, or descriptions to ensure position-specific functionality and compliance. Employees must be allowed to use different approaches to learn specific content based on convenience and preference. They should have the freedom to read a document or course content online (self-training) and sign off on their training record; managers can confirm knowledge and sign off, or assessments to verify learning can be required. This is possible with a solution like CQ Training Management Software.

How can companies demonstrate compliance with FDA training needs?

For each employee, a cloud-based solution enables the compilation of their FDA compliance training history as well as future training needs. It automates the tracking of completed courses and certifications, helping organizations easily demonstrate compliance with regulatory requirements and international standards (e.g., ISO standards, GxP requirements, and government regulations).