Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA that assure systems have the proper design, monitoring, and control of manufacturing processes and facilities. FDA assessors and investigators determine if a firm has the necessary equipment, facilities, and ability to manufacture the drug to sell in the market. By adhering to the CGMP compliance regulations, a manufacturer assures the…

Clinical reviewers evaluate the reports in FAERS in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor products’ safety after the FDA approves them.

If a potential safety concern is discovered in FDA Adverse Event Reporting System (FAERS), further evaluation is performed. Based on the evaluation, FDA may take…

IATF 16949:2016, which replaced ISO/TS 16949:2009, is an independent standard for Quality Management System (QMS) applicable to the automotive sector. Aligned to the requirements of ISO 9001:2015, it focuses on continual improvements, particularly defect prevention, reduction of waste and preventing variation in the supply chain.

To get certified, organizations need to implement a QMS aligned to…

The medical device industry manufacturers a range of technologies and applications, ranging from simple hand-held tools to more complex computer-controlled large surgical machines. While the guidance does not include a set of rigorous implementation methods, it consists of quality system requirements coupled with explanations and relevant design control principles examples. Design control is…

Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design control make a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and…

A compliance audit is a formal review of an organization’s procedures and operations mainly focusing on whether an entity is complying with internal rules, regulations, policies, decisions, and procedures. An audit report will cover the resilience of compliance preparations, security policies, risk management processes, and user access controls observed during the audit.

Compliance training is employee training authorized by regulation, legislation or policy that helps to reduce risk, maintain your reputation and improve the workplace environment to improve worker productivity in the long run. It educates your employees on the laws or regulations that are predominantly used to maintain the safety of the workplace and the dignity of the employee applicable to their job function…

FDA compliance has been designed to ensure that companies enforce QMS processes that will create higher quality products. In today’s competitive world, it is difficult for businesses to meet stringent FDA regulations as they are seeking to balance both quality control and ROI. ComplianceQuest is the leading provider of FDA GxP QMS solutions that improve your organization’s quality…

The ten objectives of CAPA FDA implementation are:

Validate that the CAPA system procedures that deal with the quality system requirements regulation have been specified and documented.

Define if appropriate sources of product and quality problems have been identified and make sure the data sources are analyzed to identify existing product and quality problems that may require corrective action.…

FDA training is necessary to remain compliant. It makes employees keep abreast of the current regulations and guidance and how to adhere to them. The FDA training program includes various subjects — from conducting inspections to responding to 483s or warning letters.

ISO 45001 certification is an International Standard for Occupational Health and Safety Management Systems that provides a practical solution for organizations to improve the safety and health of employees and other personnel proactively and prevent injury and ill-health. ISO 45001 is applicable to any organization regardless of its size, nature, and type

ISO training allows organizations to streamline and optimize their in-house training processes. It promotes any organization to:

1. Identify the proper training needs 2. Effectively train employees on ongoing processes 3. Track and manage employees training growth

Quality managers use ISO 13485:2016 audit checklist to determine if the QMS aligns with the ISO 13485 software standard requirements. The ISO 13485 audit checklist is used for internal audit while preparing the system for a third-party ISO 13485 certification audit. The ISO 13485 audit checklist allows quality managers to document evidence of compliance based on processes, standard…

An ISO 14001 checklist is used during EMS audit to check for compliance with ISO 14001:2015. This ISO 14001 checklist ensures that the current EMS meets all the required ISO standards. An ISO 14001 checklist is important as it —

1. Helps meet compliance requirements of the ISO 14001 standard 2. Records the steps of the EMS implementation process 3. Acts as a supporting document for…

ISO 14001 certification is a reliable, effective, and responsible environmental management system for business operations. The amount of human labor, time, and resources to create and implement a total EMS solution is excessively onerous for many businesses. Therefore, to provide the infrastructure to achieve ISO 14001, most EHS experts are trying to meet ISO 14001 standards relying on an…

Health and safety management systems are a key factor if you want a workplace that’s healthier and safer. Developing a health and safety program in your workplace is an efficient way of protecting your valuable asset, that is, your workers. The organization should maintain and establish procedures to respond to accidents and emergency situations and to prevent and reduce the health and safety impacts associated with them. They should provide the framework and structure to create…

HSEQ stands for Health, Safety, Environment and Quality. An HSEQ Management System is a tool aimed at quality, occupational health and safety, and the environment to prevent or mitigate both human and economic losses arising from accidents, adverse occupational exposures, and environmental events. The goal of the HSE Management System is to ensure that the organisation complies with…

Safety investigation is conducted to prevent accidents in a work environment. Safety managers must conduct an effective safety investigation periodically to ensure the safety standards are met to avoid penalties and prevent accidents.

Here are the steps that safety managers must follow while conducting a safety investigation –

1. Gather relevant information about the safety standards in…

Behavioral observation is the systematic recording of behavior by an external observer. The systematic nature of behavioral observation is characterized by detailed procedures designed to collect reliable and valid data on client behavior and the factors that control it. Behavioral observations are an opportunity to deliver both positive and constructive feedback. It is a feedback session structured around…

Hazard analysis is a continuous process that has to be performed to mitigate hazards that can be introduced at any stage from requirements, design, development, product testing, installation, commissioning, operation, system maintenance, and disposal of a system. Some of the events that could initiate hazard analysis include –

Concept definition

Reviews of requirement, design, design…