#qms

[kneipe]

berlin 2023

[shareyourideas]

A Comparison Of ISO 9001 And Quality Management System

[dramairime]

What is "IWTBN" ?

IWTBN or “It won’t turn back now” is an illustration project made by dramairime that is mostly uploaded on youtube, the series describes about a middle schooler suffering through multiple mental conditions such as Depression, PTSD (Post-traumatic stress disorder), and much terrible things. This illustration project is actually a way to spread more awareness and signs about certain mental conditions that are described through different styles of illustrations.

One of the most viewed and favorite style illustration is the paper project, I'll be posting more of these very soon soooo stay tuned! I'll post the information about the characters too ヾ(｡･ω･)ｼ !!

[odigodisse]

Eu recebi um novo certificado 🎓 E este tem muito valor para mim 😍🥰😘🤩 Mais uma meta alcançada com muito esforço 🙌👏👍👊🤘🙏🫵 Certifica que eu frequentei e concluí com sucesso a avaliação do curso 👨‍🏫📚✏️📖 realizado pelo @bureauveritasbr 🏫😍🥰😘🤩 o exame para o PR328: Curso de Formação de Auditor Líder QMS ISO 9001:2015 Curso nº 17929 certificado pelo CQI e IRCA 😍🥰😘🤩 Este curso satisfaz os requisitos de treinamento para o Sistema Certificação de Auditor CQI e IRCA QMS 🙌👏👍👊🤘🙏🫵

[nikunjbhoraniya]

➡️ What is an Equipment Breakdown? Types of Breakdowns | Examples

[radiophd]

qms -- t love

[blackbird-brewster]

Welcome to #Queerminal Minds Saturdays!

Each Saturday, I'm queuing up old Queerminal Minds posts for your viewing pleasure. Every week will focus on a different character of Criminal Minds.

This Week's Character: Jennifer Jareau

[wemahesh]

21 cfr

21 CFR stands for Title 21 of the Code of Federal Regulations. It is a set of regulations issued by the United States Food and Drug Administration (FDA) that covers various aspects of regulatory requirements for pharmaceuticals, medical devices, food, cosmetics, and other products governed by the FDA.The regulations within 21 CFR are designed to ensure the safety, efficacy, and quality of these…

[quynhhuong23]

Hệ thống quản lý chất lượng - Thông tin mới nhất năm 2024

https://ucc.com.vn/he-thong-quan-ly-chat-luong-qms/

[bizsolution]

Discover how a structured incident management process can help your organization quickly resolve issues, reduce risks, and maintain operational continuity.

[kneipe]

hamburg 2023

[edullence]

ISO 9001:2015 QMS Lead Auditor Training Course

Edullence Education Excellence offers an ISO 9001:2015 QMS Lead Auditor Training Course, designed to equip professionals with the skills to audit quality management systems effectively. This comprehensive course covers auditing principles, techniques, and ISO 9001 standards, ensuring participants gain expertise to lead successful audits and enhance organizational quality.

[rustomaapte]

Starting from 9th, 10th, 15th, 16th, 17th November 2024 Time:- 10:00 A.M. to 06:00 P.M. Indian Standard Time (IST). PLease call +91-8882213680 or training@siscertifications.com to answer your questions. SIS Certifications will be issuing certificates powered by Exemplar Global. Elevate your expertise and your organization’s performance today!

[nikunjbhoraniya]

➡️ What is a Key Performance Indicator (KPI)? Guide and Examples

[pharmatechy]

Quality Assurance in Pharma Company

The Quality Assurance department plays a major role in the Pharmaceutical industry. The quality of the products that are manufactured in the production areas from starting to following and reviewing documents from the final release or rejection of every batch of Drug substance and Products for distribution and sale. QA department ensures every stage of manufacturing of the drug substance or drug product and also monitors each processing stage and maintains all manufacturing-related documentation as per BPR, Standard Operating Procedures (SOPs). The most important activity for in-process manufacturing and critical process and quality parameters checks up to batch release. Examples: Clean condition and proper manufacturing area, temperature probes, Pressure, steam, RT water, brine, and Personal protective equipment. IPQA persons monitor the in-process and control. After completing the manufacturing batch process record reviewed all data related to product manufacturing like line clearance, raw materials, temperature times, pressure, chemist signature, any deviations, time delays etc., and a checklist of all the calculations related to Batch Processing Records(BPR). Ex: Yield calculations Type complaint based on quality and safety QA responsible action for the decision taken by HODs as per SOPs. Change Control (CCF): Any changes based on minor or major processes and validation applied required a change control form which the department finally reviewed and approved by QA within timelines. These are two types based on product quality 1) Temporary 2) Minor deviation 3) Major deviation

Deviation: The deviation is the observation of any process-related information that deviates from the standard process or Protocol. These are two types based on product quality 1) Major deviation 2) Minor deviation In case of any out results from testing given Specification Standard testing procedure. QA department investigates to find the root cause of results Out of Specification (OOS): The results are coming out of the specification These are two types of investigations. Phase 1: Laboratory investigation (Quality Control) Phase 2: Full-scale investigation (Manufacturing, warehouse and Safety) and also additional tests required for investigation. Find out the root cause of the results and decide to take corrective and preventive action so these are not repeated in future. Out-of-trend (OOT): The results are within the specification limits but do not follow the previous batch trend results and are also near the specification limits.

it indicates the process is out of control or something the process not properly follow. Whenever any market complaints came for a product or any document received an official email from a customer maintained a registered as per SOP. Internal audits: QA conducts internal audits frequently as per their SOPs to check all departments follow their SOPs. External Audits: (Regulatory and Customer) To conduct an audit by QA of their contract manufacturing units or APIs to check to follow their SOPs, guidelines and policies. Monthly conducts two hours of training oral or verbal or PPT for departments in pharma guidelines and important topics of the industry. After completing training conduct a written examination for participants persons and also an evaluation. Ex: 1) cGMP (Current Good Manufacturing Practice) 2) ICH guidelines (International Council of Harmonisation for Pharmaceuticals Human Use). Annual Product Quality Review: (APQR) Prepare annual product quality review for consistency of the manufacturing process, Quality, yield, and analytical results to be represented statistically. Mainly Quality Management Systems (QMS) activities are followed by Validations (Vendor, Process, Cleaning, Method), Qualifications (IQ, OQ, PQ), Tech transfer, Market and Customer complaints RA department requirements. Conclusion: The Quality Assurance Department have the authority of each department to Audit and implement the cGMP and Pharmaopial guidelines in the Pharmaceutical companies.