Month: June 2022

FDA Inspectors’ Inspection Checklist & Method of Compliance for CAPA Inspection – Med Devices

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FDA inspection is one of the critical elements of FDA’s role in ensuring high quality products are comings to market which does not pose a threat to public. To ensure it FDA inspects various drug and device manufacturing facilities and reviews the systems and processes time to time. These are various regulations and guidance documents Read more about FDA Inspectors’ Inspection Checklist & Method of Compliance for CAPA Inspection – Med Devices[…]

ICH Q9 – Quality Risk Management

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The purpose of Q9 is to serve as a foundational or resource document that is independent yet supports other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines. Different from other ICH guidelines and Provides a process and tools, not requirements. Risk as per ICH Q9 – The combination of the probability Read more about ICH Q9 – Quality Risk Management[…]

FDA Recall Process & Policies

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The recall of a defective or possibly harmful consumer product often is highly publicized in newspapers and on news broadcasts. This is especially true when a recall involves foods, drugs, cosmetics, medical devices, and other products regulated by FDA. Despite this publicity, FDA’s role in recall activities is often misunderstood not only by consumers, but Read more about FDA Recall Process & Policies[…]

The Americans with Disabilities Act (ADA) – Compensation & Financial Assistance

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Q.  How does the ADA affect workers’ compensation programs? A.  Only injured workers who meet the ADA’s definition of an “individual with a disability” will be considered disabled under the ADA, regardless of whether they satisfy criteria for receiving benefits under workers’ compensation or other disability laws. A worker also must be “qualified” (with or Read more about The Americans with Disabilities Act (ADA) – Compensation & Financial Assistance[…]

The Americans with Disabilities Act (ADA) – Drug Policy

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Q.  Can an employer consider health and safety when deciding whether to hire an applicant or retain an employee with a disability? A.  Yes. The ADA permits employers to establish qualification standards that will exclude individuals who pose a direct threat — i.e., a significant risk of substantial harm — to the health or safety Read more about The Americans with Disabilities Act (ADA) – Drug Policy[…]

The Americans with Disabilities Act (ADA) – Reasonable Accommodation

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Q.  What is “reasonable accommodation?” A.  Reasonable accommodation is any modification or adjustment to a job or the work environment that will enable a qualified applicant or employee with a disability to participate in the application process or to perform essential job functions. Reasonable accommodation also includes adjustments to assure that a qualified individual with Read more about The Americans with Disabilities Act (ADA) – Reasonable Accommodation[…]

The Americans with Disabilities Act (ADA) – Employer Responsibilities

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Q.  What employers are covered by title I of the ADA, and when is the coverage effective? A.  The title I employment provisions apply to private employers, State and local governments, employment agencies, and labor unions. Employers with 25 or more employees were covered as of July 26, 1992. Employers with 15 or more employees Read more about The Americans with Disabilities Act (ADA) – Employer Responsibilities[…]

The Americans with Disabilities Act (ADA) – Effect on State and Local Govts

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Q.  Is the Federal government covered by the ADA? A.  The ADA does not cover the executive branch of the Federal government. The executive branch continues to be covered by title V of the Rehabilitation Act of 1973, which prohibits discrimination in services and employment on the basis of handicap and which is a model Read more about The Americans with Disabilities Act (ADA) – Effect on State and Local Govts[…]

The Americans with Disabilities Act (ADA) – Public Accommodations

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Q.  What are public accommodations? A.  A public accommodation is a private entity that owns, operates, leases, or leases to, a place of public accommodation. Places of public accommodation include a wide range of entities, such as restaurants, hotels, theaters, doctors’ offices, pharmacies, retail stores, museums, libraries, parks, private schools, and day care centers. Private Read more about The Americans with Disabilities Act (ADA) – Public Accommodations[…]