This document provides information about an online panel discussion on GMP Quality Principles. It begins by stating that FDA inspections focus on compliance with 21 CFR 210 & 211 regarding good manufacturing practices. It then explains that understanding key GMP quality principles is more useful for daily management than the detailed regulations. The discussion will help participants learn about efficient GMP roles and responsibilities as well as the objectives of quality control, facilities, equipment, packaging and other areas. Attendees will gain a solid understanding of GMP regulations to achieve and maintain full compliance.
From unannounced audits to food fraud, what changes are in store for SQF in 2016? TraceGains hosted LeAnn Chuboff, Senior Technical Director of the Safe Quality Food Institute on March 9th, 2016 for a webinar to learn about proposed changes to the SQF Code and insights gleaned from the latest GFSI guidance to be released in early March 2016.
The webinar gave attendees a sneak peek into the proposed changes for SQF Edition 8 and other program improvements. Specifically, the SQF webinar covered:
-SQF Edition 8 implementation timeline
-Lessons learned from recalls and withdrawals
-Unannounced audit findings
-Improving auditor consistency & competency
-Incorporating FSMA and other international laws & regulations
-How food defense will be further elevated in 2016
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
In this webinar, you will learn how to optimize your CAPA program by clearly defining the problem, and understanding what questions to ask to identify the root cause of the problem.
Learn the disconnect between regulatory traceability requirements & industry standards; how KDEs needed for recall resolution compare to those in FSMA 204; & ways to fortify your traceability system
From unannounced audits to food fraud, what changes are in store for SQF in 2016? TraceGains hosted LeAnn Chuboff, Senior Technical Director of the Safe Quality Food Institute on March 9th, 2016 for a webinar to learn about proposed changes to the SQF Code and insights gleaned from the latest GFSI guidance to be released in early March 2016.
The webinar gave attendees a sneak peek into the proposed changes for SQF Edition 8 and other program improvements. Specifically, the SQF webinar covered:
-SQF Edition 8 implementation timeline
-Lessons learned from recalls and withdrawals
-Unannounced audit findings
-Improving auditor consistency & competency
-Incorporating FSMA and other international laws & regulations
-How food defense will be further elevated in 2016
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
In this webinar, you will learn how to optimize your CAPA program by clearly defining the problem, and understanding what questions to ask to identify the root cause of the problem.
Learn the disconnect between regulatory traceability requirements & industry standards; how KDEs needed for recall resolution compare to those in FSMA 204; & ways to fortify your traceability system
Ongoing, monthly FSMA webcast series featuring The Acheson Group.
In the April 2018 session, Cameron Prince, Senior Food Safety Director with The Acheson Group, joined us for an update on current FSMA activities and to discuss the Safe Food For Canadians Act. Cameron provided an overview of the key elements of the act and proposed regulations and the impact on current food safety environment.
To learn more about this ongoing series, visit www.FSMAFridays.com.
The Challenges of an Effective Change Control Program and How to Address OOS ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
Inside the Mind of a Food Safety AuditorTraceGains
Audits are daunting, seemingly never-ending, and appear to be increasing rather than waning in frequency. Preparing for an audit is equally stressful not to mention unannounced audits...
-How do you know that you are focusing on the right things to prepare for an audit?
-Are you ever caught off guard by any of the questions an auditor asks?
-How can you make sure your food safety plan actually matches up with your day-to-day operations?
-What are the keys to building and maintaining a food safety culture, so that you are always prepared?
If you've ever pondered any of those questions, join TraceGains as we explore these topics and get inside the mind of a real food safety auditor.
Featuring
Nancy Scharlach, President & Chief Technical Director of Soterian Systems, LLC
the challenges of an effective change control program and how to address oos ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
Preparing for New FSMA Preventive Controls RegulationsAlchemy Systems
FDA's current deadline for publishing the final rules for preventative controls for is quickly approaching. Find out what your company needs to know to prepare for these new regulatory requirements for FDA-regulated processors. This presentation provides an overview of preventative controls requirements under the Food Safety Modernization Act (FSMA), what is HARPC, and how to make the HACCP to HARPC conversion, as well as reassessing food safety plans for compliance and effectiveness.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Temperature controlled transport according to current EU GDPPauwels Consulting
In this presentation, Luc Huybreghts discusses the new EU GDP on the storage, transport and distribution of pharmaceutical products. For more information, visit http://www.pconsulting.net/eu-gdp
Ongoing, monthly FSMA webcast series featuring The Acheson Group.
In the April 2018 session, Cameron Prince, Senior Food Safety Director with The Acheson Group, joined us for an update on current FSMA activities and to discuss the Safe Food For Canadians Act. Cameron provided an overview of the key elements of the act and proposed regulations and the impact on current food safety environment.
To learn more about this ongoing series, visit www.FSMAFridays.com.
The Challenges of an Effective Change Control Program and How to Address OOS ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
Inside the Mind of a Food Safety AuditorTraceGains
Audits are daunting, seemingly never-ending, and appear to be increasing rather than waning in frequency. Preparing for an audit is equally stressful not to mention unannounced audits...
-How do you know that you are focusing on the right things to prepare for an audit?
-Are you ever caught off guard by any of the questions an auditor asks?
-How can you make sure your food safety plan actually matches up with your day-to-day operations?
-What are the keys to building and maintaining a food safety culture, so that you are always prepared?
If you've ever pondered any of those questions, join TraceGains as we explore these topics and get inside the mind of a real food safety auditor.
Featuring
Nancy Scharlach, President & Chief Technical Director of Soterian Systems, LLC
the challenges of an effective change control program and how to address oos ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
Preparing for New FSMA Preventive Controls RegulationsAlchemy Systems
FDA's current deadline for publishing the final rules for preventative controls for is quickly approaching. Find out what your company needs to know to prepare for these new regulatory requirements for FDA-regulated processors. This presentation provides an overview of preventative controls requirements under the Food Safety Modernization Act (FSMA), what is HARPC, and how to make the HACCP to HARPC conversion, as well as reassessing food safety plans for compliance and effectiveness.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
Temperature controlled transport according to current EU GDPPauwels Consulting
In this presentation, Luc Huybreghts discusses the new EU GDP on the storage, transport and distribution of pharmaceutical products. For more information, visit http://www.pconsulting.net/eu-gdp
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
The subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has continued to receive a large amount of attention from regulators, companies and customers alike.
The integration of Cleaning Validation within an effective Quality System supported by Quality Risk Management Processes should give assurance that API Manufacturing Operations are performed in such a way that Risks to patients related to cleaning validation are understood, assessed for impact and are mitigated as necessary.
It is important that the requirements for the finished manufacturing companies are not transferred back in the process to active pharmaceutical ingredient manufacturers without consideration for the different processes that take place at this stage.
This presentation covers the requirements of Cleaning Validation for a Multipurpose API Manufactuirng Plant
Active Pharma Ingredients (API) - Global Market Estimated to Reach US$ 21.9 b...Ajjay Kumar Gupta
Active Pharma Ingredients (API) - Global Market Estimated to Reach US$ 21.9 billion by 2023: Investment Opportunity for Startups and Entrepreneurs, Medications, Drugs and Pharmaceuticals, Cephalexin Monohydrate, Ampicilin Trihydrate, Ibuprofen Manufacturing Plant, Detailed Project Report, Profile, Business Plan, Industry Trends, Market Research, Survey, Manufacturing Process, Machinery, Raw Materials, Feasibility Study, Investment Opportunities, Cost and Revenue, Plant Economics, Production Schedule, Working Capital Requirement, Plant Layout, Process Flow Sheet, Cost of Project, Projected Balance Sheets, Profitability Ratios, Break Even Analysis
Production of active pharmaceutical ingredients is a highly sophisticated and technically demanding process. The global active pharmaceutical ingredient market is surging due to the increased demand for pharmaceutical drugs, which in turn is driven by aging population, increasing prevalence of chronic diseases such as cancer, diabetes, cardiovascular, neurological and infectious diseases among others. The global Active Pharmaceutical Ingredient market for was valued at US$ 12.9 bn in 2014 and is estimated to reach US$ 21.9 billion by 2023 at a CAGR of 6.3% from 2015 to 2023.
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Good Manufacturing Practice, or GMP, is a set of practices and systems that are aimed at making sure that pharmaceutical products are manufactured in conformance with set requirements and standards. The aim of GMP also referred to sometimes as cGMP or Current Good Manufacturing Practice, is to ensure that there is control and consistency in the pharmaceutical products, so that the processes used for controlling quality and consistency of the product can be traced back in the event of a problem.
This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
The 7 Deadly Sins of Quality Assurance and Quality Control - Pharma IQ eBookPharma IQ
The Seven Sins of QA and QC are those transgressions which are detrimental to quality and profitability. You will probably commit some of them every day. We asked the global pharmaceutical community what they thought were the biggest sins that people commit in quality assurance and quality control and the same ones kept coming up over and over again.
Description:
This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management.
Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.
Webinar on how manufacturers implementing good manufacturing practices managed by quality systems can be in the best compliance with parts 210 and 211.
Requirements for Establishing an Effective Cleaning Validation ProgramGlobalCompliancePanel
This 2 day course will cover practical guidance on cleaning validation
regulatory compliance, in conjunction with, risk-based, reasonable and
informed decision making and activity planning. This two day
interactive course will cover fundamental principles of a cleaning
validation program, exploring such concepts as the determination of
residues to be targeted, selection of analytical and sampling methods,
determination of appropriate limits in various pharmaceutical and
biotechnology processes, and establishment of scientific rationales
acceptable to regulatory inspectors.
GMP stands for Good Manufacturing Practices and is a list of guidelines for procedures, procedures, and documentation that assures that the label on the product accurately represents the actual components of the product.
For more detail Visit these sites.
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
As a business owner in Delaware, staying on top of your tax obligations is paramount, especially with the annual deadline for Delaware Franchise Tax looming on March 1. One such obligation is the annual Delaware Franchise Tax, which serves as a crucial requirement for maintaining your company’s legal standing within the state. While the prospect of handling tax matters may seem daunting, rest assured that the process can be straightforward with the right guidance. In this comprehensive guide, we’ll walk you through the steps of filing your Delaware Franchise Tax and provide insights to help you navigate the process effectively.
Explore our most comprehensive guide on lookback analysis at SafePaaS, covering access governance and how it can transform modern ERP audits. Browse now!
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Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
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Remote sensing and monitoring are changing the mining industry for the better. These are providing innovative solutions to long-standing challenges. Those related to exploration, extraction, and overall environmental management by mining technology companies Odisha. These technologies make use of satellite imaging, aerial photography and sensors to collect data that might be inaccessible or from hazardous locations. With the use of this technology, mining operations are becoming increasingly efficient. Let us gain more insight into the key aspects associated with remote sensing and monitoring when it comes to mining.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
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According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...
Gmp quality principles
1. GMP Quality Principles- Online Compliance Panel
Description:
We all know that when FDA appears at your door to conduct an inspection, 99% of the time, they want
to ascertain if you are in compliance with the requirements stated in 21 CFR 210 & 211 - more
commonly known as the Current Good Manufacturing Practice Regulations in Manufacturing,
Processing, Packing, or Holding of Drugs.
On the internet, this portion of the CFR occupies 23 double column pages of fine print. While every
practitioner in the pharmaceutical manufacturing and quality management business needs to have a
copy of this information available when a specific question arises, for every day management and
control of the GMP regulations a solid understanding of the GMP Quality Principles is more useful and
can be the basis for assuring cGMP compliance.
Why Should you Attend:
Stories of problems encountered by pharmaceutical manufacturers who are found to fail FDA
inspections and subsequent follow-ups are known to everyone in the industry. Manufacturing facilities
have been closed pending changes needed to achieve full compliance and fines of $500,000,000 have
been assessed. A solid knowledge of the principles of GMP Quality standards can be your day-to-day
guideline for creating and maintaining full compliance with the GMP regulations.
Full compliance must be a top objective of everyone in this industry. The big question for most of us is
how to achieve this necessary goal and still have time to complete our assigned responsibilities. To
accomplish this, we have analyzed the GMP regulations and summarized them in a few basic GMP
Quality Principles. Knowledge and use of these principles will not eliminate the need to have a copy of
the regulations for reference, but it will answer most questions quickly and effectively.
Learning objectives:
Learning about the role and responsibilities of an efficient and effective GMP proponent and developing
a solid understanding of the GMP regulations.
Objectives of the Presentation:
Responsibility of the Quality Control Unit
Required qualities of buildings & facilities
2. Equipment
Control of components and drug product containers
Process controls
Packaging and Labeling
Warehousing and Distribution
Laboratory controls
Records and Reports
Returned and Salvaged product
Who can Benefit: This webinar will provide valuable assistance to all personnel in:
Personnel interested in exploring the fields of pharmaceutical manufacturing
New pharmaceutical manufacturing and quality supervisors and managers
Administrative managers in charge of pharmaceutical manufacturing or quality
Pharmaceutical manufacturing and quality Associates and Manager
Live Session - How it works
We will send Username and password 24 hours prior to webinar at your email address.
Webinar presentation handouts will be shared in pdf format, a day before live presentation.
Use the login details to participate in sessions.
Clear out your queries through interactive Q&A chat boxes with the speaker.
We need to know your experience, so please don't skip to provide us with your overall presentation
feedback.
Get certification of attendance.
Recorded Session - How it works
Once you purchase a webinar you will receive username and password at your email address.
Use the login details to view recorded webinars.
Presentation handouts will also be shared in pdf format.
Access to the recording is valid only till 6 months starting from the date of purchase.