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Establishing Effective Employee Training Programs for Medical Device Companies: What Works and What Doesn't
This webinar will focus on how to establish an effective training program, at medical device companies, that will not only prepare you for an FDA inspection but will also enhance your overall business performance.
Why Should You Attend:
The USFDA requires that device manufacturers train their personnel. The requirement for training for medical device firms is contained in 21 CFR 820.25(b). During agency inspections, the investigator will check training records to see that your firm’s training program is adequate.
Designing an effective employee training program is a crucial building block for your overall Quality System. Being able to effectively demonstrate that you’ve hired employees with the right amount of education, background, training, and experience is only half the battle. The FDA also expects employees to stay up-to-date with internal, job-specific and quality related training for the entire length of their tenure with the company. During FDA inspections, the training system and training records can become a central area of concern if a company is not able to readily produce records that demonstrate control in this area.
This webinar will focus on how to establish an effective training program that will not only prepare you for an FDA inspection but will also enhance your overall business performance.
Areas Covered in the Webinar:
- Overview of Regulation.
- Review of recent Warning Letters.
- What’s expected by the FDA.
- What doesn’t work and why.
- What works and why.
- FDA readiness.
- Business efficiency
Who Will Benefit:
- Quality System Professionals
- Quality Assurance
- Company Training Coordinators
- Operations Supervisors and Managers
- Human Resources
- Quality Auditors
Melita Ball, held Corporate Director-level leadership positions in Quality and Regulatory Compliance for Medical Device and Diagnostic companies for 17 years before she opened her consulting firm in 2006. Since then, MBC & Affiliates, LLC has grown from a one person independent consultant to a successful Life Sciences consulting firm with a team of highly qualified consultants ready to help clients tackle the most challenging compliance issues facing Medical Device and Diagnostic companies today.
Ms. Ball serves as the company’s Principal Consultant with expertise in Regulatory & Quality Training, Remediation, Warning Letter mitigation, Quality System Development, 21 CFR Part 11 expertise, Software Validation, Supplier Qualification & Management, Quality Auditing, CAPA, Management Controls, and Project Management.
Associate Consultants provide specific expertise in such areas as Design Controls, Document, Record, & Change Controls, Production & Process Controls, Bioinformatics, Biostatistics, Clinical Affairs, Regulatory Affairs, Sterilization Validation, Facility Qualification & Registration, and Quality Auditing (ISO, FDA, CMDR, MDD, and JPAL).
MBC & Affiliates, LLC uses a team approach to partner with their clients to achieve world class results.
FDA Quality System Regulation (QSR)
The FDA’s Quality System Regulation or QSR is a cornerstone of medical device good manufacturing practices (GMP). The QSR is codified as 21 CFR 820 and applies to all finished device manufacturers who intend to commercially distribute medical devices. According to the regulations, a finished device is ‘any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.’
As there are a wide variety of devices falling into different classifications according to risk and safety issues, the regulations themselves don’t go into detail for each of these types. Instead, manufacturers are to use their own judgment and see which part of the QSR applies to their requirements. The FDA therefore expects each manufacturer to use the QSR as a guideline to make devices that are safe and effective and to implement procedures to design, produce, distribute and manage devices that meet the QSR requirements.
FDA Inspections and Warning Letters
The FDA inspects or audits manufacturers and processors of FDA regulated products such as drugs, devices, food etc in order to verify that they are in compliance with the agency’s regulatory requirements. FDA inspectors also conduct inspections of clinical trial sites, laboratories undertaking studies related to FDA approval of a medicinal product, foreign manufacturing and processing sites where FDA regulated products to be sold in the US are being made, and imported products at the border.
Among the types of inspections that the FDA conducts are: pre-approval inspections, routine facility inspections and “for cause” inspections.
The FDA defines a warning letter as a correspondence that notifies the regulated business about violations found during a recent FDA inspection of its premises. Warning letters are only issued for violations of “regulatory significance”, i.e. those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected.
21 CFR 820.25(b)
One of the requirements in the FDA’s QSR is that the manufacturer should identify training needs amongst its personnel and provide the training necessary to ensure that all personnel are adequately performing their assigned duties. This training should be documented. The FDA also requires that as part of the training process, personnel are made aware of device defects that may arise from improper performance of their specific tasks. Those employees who perform verification and validation activities should be made aware of the errors and defects that they may encounter as part of their jobs.
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