Imacor GMP Quiz 2014

Explanation
The correct answer is "All of the Above" because the Food and Drug Administration (FDA) is the US regulatory body that oversees various areas related to food and drug safety. CFR 820 refers to the Code of Federal Regulations Title 21, which outlines the quality system requirements for medical devices. Therefore, all the options mentioned are covered by the FDA.

Explanation
The statement is true because the responsibility of the Management Representative is indeed documented in the Quality Manual. The Quality Manual is a document that outlines the quality management system of an organization and provides information on the roles, responsibilities, and authorities of the personnel involved. The Management Representative is a key role in ensuring the effective implementation and maintenance of the quality management system, and their responsibilities are typically documented in the Quality Manual to provide clarity and guidance to all personnel involved in quality management activities.

Explanation
GMP stands for Good Manufacturing Practices. These practices ensure that products are consistently produced and controlled according to quality standards. They cover various aspects of production, including hygiene, equipment maintenance, documentation, and staff training. The term "Good" refers to the high quality and standards followed in the manufacturing process, while "Manufacturing" indicates the focus on production activities. "Practices" emphasizes the systematic and consistent approach required to meet these standards.

Explanation
Not all medical device companies are required to be ISO 13485 registered. ISO 13485 is an international standard for quality management systems specific to the medical device industry. While many medical device companies choose to become ISO 13485 registered to demonstrate their commitment to quality and regulatory compliance, it is not a mandatory requirement for all companies. Some companies may choose to follow alternative quality management systems or may not be subject to regulatory requirements that necessitate ISO 13485 registration.

Explanation
The correct answer is "Medical Device Directive." The question is asking about the European legislation known as 93/42/EEC, which is commonly referred to as the Medical Device Directive. This directive sets out the regulatory requirements for medical devices in the European Union, including the classification, safety, and performance standards that must be met for these devices to be marketed and sold within the EU.

Explanation
CAPA stands for Corrective and Preventive Action. It is a systematic approach used to identify, investigate, and resolve issues or non-conformities in order to prevent their recurrence. The acronym does not include the term "Presents" and instead refers to the actions taken to correct and prevent problems. Therefore, the correct answer is False.

Explanation
The FDA has the authority to fine ImaCor, recall an ImaCor product, and prosecute employees of ImaCor. However, it does not have the authority to inspect ImaCor facilities. This means that while the FDA can take action against ImaCor for violations, it does not have the power to physically inspect their facilities to ensure compliance with regulations.

Explanation
In order to maintain a quality management system (QMS), it is necessary to have control over all work instructions, standard operating procedures (SOPs), forms, databases, and other related documents. This control ensures that these documents are up-to-date, accurate, and accessible to the relevant personnel. By implementing control measures, organizations can ensure consistency, compliance, and continuous improvement within their QMS. Therefore, it is true that all QMS work instructions, SOPs, forms, databases, etc. should be controlled.

Explanation
When a nonconforming product is discovered, the appropriate action is to notify the Quality or Program Manager. They will then conduct a root cause analysis to determine the underlying cause of the nonconformity. This analysis helps in identifying the factors that led to the issue, enabling the organization to take appropriate actions such as repairing, destroying, or setting aside the product. Calling the FDA or preventing the product from unintended use may not be the immediate requirement in this scenario.

Explanation
The correct answer is S-drive because the S-drive is a designated storage location where the Quality Manual, Quality Policy, and Quality SOP's can be found. This indicates that these documents are stored and organized in a specific drive, separate from the G-drive and C-drive options.