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Compliance Regulations and Guidance Affecting your Industry

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21CFR Part 820 - Quality System Regulation-Part02

  • Industry: Quality Management

According to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

21 CFR Part 820 - Quality System Regulation-Part-1

  • Industry: Quality Management

According to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

Title 21: Food and Drugs Part 120 — Hazard Analysis and Critical Control Point (HACCP) Systems

  • Industry: Quality Management

An evaluation of each food hazard identified to determine if the hazard is reasonably likely to occur and thus, constitutes a food hazard that must be addressed in the HACCP plan.

9CFR417- HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

  • Industry: Quality Management

The Hazard Analysis Critical Control Point system (HACCP) has become the universally recognized and accepted method for food safety assurance. The recent and growing concern about food safety from public health authorities, food industry and consumers worldwide has been the major impetus in the application of the HACCP system. This concern has been substantiated by a significant increase in the incidence of foodborne diseases in many countries during recent years.

21CFR Part 820 - Quality System Regulation

  • Industry: Quality Management

According to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

TITLE 21 PART 820 QUALITY SYSTEM REGULATION

  • Industry: Quality Management

Aaccording to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

 

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