Food Industry Solutions LLC provides services to address common challenges in the food industry, including quality control and food safety, outsourced food service operations, self-operated food service, sustainability, and regulatory compliance. The document outlines FIS's value matrix matching their offered services to company needs. It introduces the three principals - Morten Blomsø, Tony Morro, and Dr. Cayce Warf - and their relevant expertise. The agenda includes discussing goals, services, industry challenges, and identifying areas of potential collaboration between FIS's qualifications and a company's needs.
This document discusses Coca Cola India's approach to food safety management. It outlines the importance of quality, food safety, and reputation to the company's corporate reputation. It emphasizes ensuring food safety across the entire supply chain from raw materials to production to distribution to customers. The company has world-class food safety management standards and systems in place to meet all regulatory requirements and consumer expectations. Food safety is a top priority in manufacturing, where the culture emphasizes awareness and compliance with practices even when unobserved.
The document describes a case study on the development of a solid dispersion formulation of lacidipine using quality by design principles. The objectives were to develop a stable formulation to enhance lacidipine's solubility, dissolution, and bioavailability without the need for surfactants, disintegrants or micronization. Various studies were conducted to optimize the drug to carrier ratio and processing parameters. Formulations were evaluated for assay, impurities, disintegration time, and dissolution profile. The best formulation had a drug to carrier ratio of 1:10, intragranular to extragranular lactose ratio of 80:20, lubricant level of 0.25%, and film coating of 1% weight gain.
Alkermes Contract Pharma Services provides solid oral dosage and sterile injectable manufacturing services. With over 40 years of experience, they have proven expertise in drug product development, manufacturing, and launching 12 commercial products. Their facilities in the US and Europe employ over 870 people and offer a full range of development, manufacturing, packaging, and quality assurance services to partner companies.
Quality by-Design (QbD) by Mr. Nitin Kadam.Nitin Kadam
QbD is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. A QbD-based ANDA should include a demonstration of process understanding through identification of critical process parameters and a control strategy to ensure the product reliably meets predefined objectives. Key aspects of QbD include defining quality target product profiles, identifying critical quality attributes and risks, design of experiments for optimization, and establishing a design space and control strategy.
This document provides a summary of RJ Cook's qualifications and professional experience in quality control, quality assurance, and regulatory affairs over 28 years. It lists roles at various biotechnology companies where responsibilities included GMP quality assurance, auditing, regulatory submissions, establishing quality systems, and ensuring compliance. Key accomplishments include launching an approved drug product in Europe and establishing deviation monitoring processes.
The document discusses a presentation on applying Quality by Design (QbD) principles for biotech and specialty pharma companies. It provides an overview of the presentation's objectives, which are to provide perspective on applying QbD during development and constructing regulatory documents in parallel with development milestones. The outline discusses drivers for QbD like ICH guidelines, incentives like more efficient change control and reduced testing, and barriers like additional costs and resistance to change.
GCP-Service is a full-service clinical research organization that provides clinical operations and quality assurance services across Europe and the US. It has a highly trained staff of over 80% with academic educations. GCP-Service has experience conducting all phases of clinical trials for pharmaceutical, biotechnology, and medical device clients across many therapeutic areas. It offers specialized services for pediatric and oncology studies in addition to its full range of clinical trial services.
This document discusses Coca Cola India's approach to food safety management. It outlines the importance of quality, food safety, and reputation to the company's corporate reputation. It emphasizes ensuring food safety across the entire supply chain from raw materials to production to distribution to customers. The company has world-class food safety management standards and systems in place to meet all regulatory requirements and consumer expectations. Food safety is a top priority in manufacturing, where the culture emphasizes awareness and compliance with practices even when unobserved.
The document describes a case study on the development of a solid dispersion formulation of lacidipine using quality by design principles. The objectives were to develop a stable formulation to enhance lacidipine's solubility, dissolution, and bioavailability without the need for surfactants, disintegrants or micronization. Various studies were conducted to optimize the drug to carrier ratio and processing parameters. Formulations were evaluated for assay, impurities, disintegration time, and dissolution profile. The best formulation had a drug to carrier ratio of 1:10, intragranular to extragranular lactose ratio of 80:20, lubricant level of 0.25%, and film coating of 1% weight gain.
Alkermes Contract Pharma Services provides solid oral dosage and sterile injectable manufacturing services. With over 40 years of experience, they have proven expertise in drug product development, manufacturing, and launching 12 commercial products. Their facilities in the US and Europe employ over 870 people and offer a full range of development, manufacturing, packaging, and quality assurance services to partner companies.
Quality by-Design (QbD) by Mr. Nitin Kadam.Nitin Kadam
QbD is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. A QbD-based ANDA should include a demonstration of process understanding through identification of critical process parameters and a control strategy to ensure the product reliably meets predefined objectives. Key aspects of QbD include defining quality target product profiles, identifying critical quality attributes and risks, design of experiments for optimization, and establishing a design space and control strategy.
This document provides a summary of RJ Cook's qualifications and professional experience in quality control, quality assurance, and regulatory affairs over 28 years. It lists roles at various biotechnology companies where responsibilities included GMP quality assurance, auditing, regulatory submissions, establishing quality systems, and ensuring compliance. Key accomplishments include launching an approved drug product in Europe and establishing deviation monitoring processes.
The document discusses a presentation on applying Quality by Design (QbD) principles for biotech and specialty pharma companies. It provides an overview of the presentation's objectives, which are to provide perspective on applying QbD during development and constructing regulatory documents in parallel with development milestones. The outline discusses drivers for QbD like ICH guidelines, incentives like more efficient change control and reduced testing, and barriers like additional costs and resistance to change.
GCP-Service is a full-service clinical research organization that provides clinical operations and quality assurance services across Europe and the US. It has a highly trained staff of over 80% with academic educations. GCP-Service has experience conducting all phases of clinical trials for pharmaceutical, biotechnology, and medical device clients across many therapeutic areas. It offers specialized services for pediatric and oncology studies in addition to its full range of clinical trial services.
This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development and manufacturing that emphasizes product and process understanding. It discusses key QbD concepts like critical quality attributes, design space, and control strategy. The document also outlines some advantages of QbD like improved quality, flexibility, and reduced regulatory oversight. Finally, it examines implications of QbD for various technical roles, including new skills needed and a shift towards more predictive and science-based approaches.
This document provides an overview of Ecolab's performance in 2006 and outlook for 2007 across its various business units. In 2006, Ecolab achieved strong sales growth and record performance across many business units by focusing on new customer acquisition, successful programs like 360° Protection and Circle the Customer, and new product innovations. Heading into 2007, Ecolab expects continued growth driven by further investments in sales, service, technology and research and development to provide even greater value to customers.
The document summarizes a case study on the implementation of Quality by Design (QbD) principles in developing a film-coated tablet with an active layer to protect an unstable drug. Key aspects included identifying critical quality attributes of content uniformity and potency. Design of experiments was used to establish a design space. In-line monitoring techniques like Raman spectroscopy were utilized to ensure consistent coating quality during scale-up.
The document is an invitation and agenda for the "Partnerships for Drug Delivery Conference" taking place April 26-28, 2010 in Philadelphia, PA. It outlines the schedule of sessions and presentations focused on drug delivery partnerships, licensing opportunities, and innovations. Key details include:
- Register by March 12, 2010 to receive up to $600 off registration fees.
- Sessions will discuss identifying partnership opportunities, addressing patent strategies, leveraging alliance management, FDA approval processes, and case studies.
- Presentations from major pharmaceutical companies like AstraZeneca, Merck, Pfizer, and Novo Nordisk.
- Networking opportunities with industry professionals from areas like business development, licensing, and regulatory affairs
GCP-Service is a full-service clinical research organization (CRO) with headquarters in Bremen, Germany and offices in Poland and Belgium. They provide clinical operations and quality assurance services globally across multiple therapeutic areas including oncology, paediatrics, and medical devices. GCP-Service aims to deliver high quality clinical trial services at competitive prices through investing in employee training and a quality management system. They have extensive experience conducting various phases of clinical trials and have enrolled over 25,000 patients across many countries in Europe and the US.
This document provides an overview of a workshop on quality by design (QbD) for generic drugs. It discusses the following key points:
1. The workshop consists of 5 sessions covering topics like QbD overview, quality target product profiles, product and process design and understanding, control strategy, and generic drug user fees.
2. The FDA is implementing QbD for generic drugs to enhance knowledge sharing, reduce costs from poor quality, and improve consumer confidence in generics. Full implementation is targeted for January 2013.
3. For generic drug applications, the FDA will expect submissions to include a quality target product profile, identification of critical quality attributes and critical process parameters, and a control strategy. This represents
Quality by Design A Present to Future Perspectiveijtsrd
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design QbD and describes use of Quality by Design to ensure quality of Pharmaceuticals. The Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. Mr. Rajesh Dumpala | Ms. Jaini Bhavsar | Mr. Chirag Patil "Quality by Design: A Present to Future Perspective" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd32985.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/32985/quality-by-design-a-present-to-future-perspective/mr-rajesh-dumpala
BioDuro is a contract research organization founded in 2005 in San Diego that provides discovery, development and manufacturing services across multiple facilities in the US and China. It has grown to over 600 employees and offers capabilities across discovery, preclinical and clinical development, including medicinal chemistry, DMPK, formulation development, analytical testing and cGMP manufacturing. BioDuro values accountability, integrity, results, respect and tenacity in serving its clients' needs.
This document discusses the origins and evolution of total quality management (TQM). It traces TQM from its roots in quality inspection and control to more modern approaches that emphasize continuous improvement, customer focus, employee involvement, and management commitment. The key figures and principles of TQM pioneers like Deming, Juran, and Crosby are examined. The document also outlines best practices for developing and implementing a project quality plan within an organization.
AxSource is a healthcare and information technology solutions provider specializing in consulting services for various industries including pharmaceutical, biologics, medical devices, and food. They provide regulatory, quality, engineering and IT consulting services to help clients with activities like new product launches and emerging market operations. AxSource consists of highly qualified consultants with decades of experience in North America, Europe, Mexico, and Asia.
This document summarizes a presentation on Quality by Design (QbD) given at the 44th International SFSTP Congress on June 6-7, 2012. It discusses key QbD concepts like the quality target product profile, critical quality attributes, design space, and control strategy. It provides examples of applying QbD for drug substances and products. The document also reviews regulatory guidance on QbD and tips for including a QbD approach in marketing authorization applications. Implementing QbD can help improve process understanding, monitoring, and control while reducing testing and facilitating continuous improvement and change management.
- The document discusses strategies for marketing multiple drug brands for the same indication without cannibalizing existing brands.
- It finds that introducing a new brand usually benefits companies through increased market share and reputation, though it can also cause product confusion.
- Companies minimize cannibalization most effectively by targeting different patient subtypes and aligning with thought leaders.
- Most companies market related products together as a franchise rather than separately, with efficacy often being the top differentiator between brands.
The document discusses Thermo Scientific's leadership in serving science through analytical instruments, equipment, reagents, software and services. It highlights the company's size and scale, unmatched capabilities, portfolio of leading brands, and mission to make the world healthier, cleaner and safer. Key strengths include global industry leadership, ability to continuously invest in growth opportunities through R&D, and an excellent track record of financial performance. New products are presented for applications such as sample preparation, analysis, and data interpretation.
V. L. Kanthachari Pusapati has nearly 20 years of experience in the pharmaceutical industry. He is currently the General Manager of Validation at Sun Pharma Industries, where he leads validation activities across all of Sun Pharma's manufacturing sites globally. Previously, he held roles such as Director of Quality Assurance Validation at Gland Pharma and Hospira Healthcare. He has extensive expertise in validation processes, computer system validation, and ensuring compliance with Good Manufacturing Practices and regulatory requirements.
NewLook International, Inc. Contractor Training Presentation discusses the specifics of concrete, how its made, how to prepare concrete, how to decorative concrete with concrete stains, and how to maintain concrete with NewLook's preparation products. Business development information, the available options within the decorative concrete industry and more are included in this comprehensive training program.
The document discusses decorative concrete techniques presented at the World of Concrete conference in January 2012. It features case studies and photos of various decorative concrete projects using techniques like stamped concrete, stains and dyes, polished concrete, and exposed aggregate. The projects include pool decks, patios, bridges, and more. Contractors from across the United States installed the projects using decorative concrete methods.
The document discusses concrete patios and their benefits. It notes that concrete patios are versatile and durable, and can be stamped or textured to resemble other materials like brick or stone at a lower cost. It provides examples of popular stamped patterns used in different regions and notes that stamped concrete allows homeowners to create unique outdoor spaces that blend with their homes and landscaping.
SQF Certification for Packaging Companies = Food Safety SuccessSCS Global Services
As the packaging industry gears up for SQF, industry members should be well acquainted with the rigors of the program as well as the opportunities it represents. This presentation describes the drivers for SQF in the food packaging industry, the requirements for becoming certified, as well as SQF training options for getting started.
This document discusses the use of industrial waste materials as partial replacements for cement in concrete. Some common industrial wastes that can be used include fly ash, red mud, microsilica, ground granulated blast furnace slag, rice husk ash, and metakaolin. Using these materials improves the performance of concrete while also providing environmental benefits such as reducing the use of raw materials and fossil fuels in cement production and diverting waste from landfills. The document reviews the effects of different waste materials on the properties of concrete such as workability, compressive strength, tensile strength, and modulus of elasticity.
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development and manufacturing that emphasizes product and process understanding. It discusses key QbD concepts like critical quality attributes, design space, and control strategy. The document also outlines some advantages of QbD like improved quality, flexibility, and reduced regulatory oversight. Finally, it examines implications of QbD for various technical roles, including new skills needed and a shift towards more predictive and science-based approaches.
This document provides an overview of Ecolab's performance in 2006 and outlook for 2007 across its various business units. In 2006, Ecolab achieved strong sales growth and record performance across many business units by focusing on new customer acquisition, successful programs like 360° Protection and Circle the Customer, and new product innovations. Heading into 2007, Ecolab expects continued growth driven by further investments in sales, service, technology and research and development to provide even greater value to customers.
The document summarizes a case study on the implementation of Quality by Design (QbD) principles in developing a film-coated tablet with an active layer to protect an unstable drug. Key aspects included identifying critical quality attributes of content uniformity and potency. Design of experiments was used to establish a design space. In-line monitoring techniques like Raman spectroscopy were utilized to ensure consistent coating quality during scale-up.
The document is an invitation and agenda for the "Partnerships for Drug Delivery Conference" taking place April 26-28, 2010 in Philadelphia, PA. It outlines the schedule of sessions and presentations focused on drug delivery partnerships, licensing opportunities, and innovations. Key details include:
- Register by March 12, 2010 to receive up to $600 off registration fees.
- Sessions will discuss identifying partnership opportunities, addressing patent strategies, leveraging alliance management, FDA approval processes, and case studies.
- Presentations from major pharmaceutical companies like AstraZeneca, Merck, Pfizer, and Novo Nordisk.
- Networking opportunities with industry professionals from areas like business development, licensing, and regulatory affairs
GCP-Service is a full-service clinical research organization (CRO) with headquarters in Bremen, Germany and offices in Poland and Belgium. They provide clinical operations and quality assurance services globally across multiple therapeutic areas including oncology, paediatrics, and medical devices. GCP-Service aims to deliver high quality clinical trial services at competitive prices through investing in employee training and a quality management system. They have extensive experience conducting various phases of clinical trials and have enrolled over 25,000 patients across many countries in Europe and the US.
This document provides an overview of a workshop on quality by design (QbD) for generic drugs. It discusses the following key points:
1. The workshop consists of 5 sessions covering topics like QbD overview, quality target product profiles, product and process design and understanding, control strategy, and generic drug user fees.
2. The FDA is implementing QbD for generic drugs to enhance knowledge sharing, reduce costs from poor quality, and improve consumer confidence in generics. Full implementation is targeted for January 2013.
3. For generic drug applications, the FDA will expect submissions to include a quality target product profile, identification of critical quality attributes and critical process parameters, and a control strategy. This represents
Quality by Design A Present to Future Perspectiveijtsrd
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design QbD and describes use of Quality by Design to ensure quality of Pharmaceuticals. The Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. Mr. Rajesh Dumpala | Ms. Jaini Bhavsar | Mr. Chirag Patil "Quality by Design: A Present to Future Perspective" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd32985.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/32985/quality-by-design-a-present-to-future-perspective/mr-rajesh-dumpala
BioDuro is a contract research organization founded in 2005 in San Diego that provides discovery, development and manufacturing services across multiple facilities in the US and China. It has grown to over 600 employees and offers capabilities across discovery, preclinical and clinical development, including medicinal chemistry, DMPK, formulation development, analytical testing and cGMP manufacturing. BioDuro values accountability, integrity, results, respect and tenacity in serving its clients' needs.
This document discusses the origins and evolution of total quality management (TQM). It traces TQM from its roots in quality inspection and control to more modern approaches that emphasize continuous improvement, customer focus, employee involvement, and management commitment. The key figures and principles of TQM pioneers like Deming, Juran, and Crosby are examined. The document also outlines best practices for developing and implementing a project quality plan within an organization.
AxSource is a healthcare and information technology solutions provider specializing in consulting services for various industries including pharmaceutical, biologics, medical devices, and food. They provide regulatory, quality, engineering and IT consulting services to help clients with activities like new product launches and emerging market operations. AxSource consists of highly qualified consultants with decades of experience in North America, Europe, Mexico, and Asia.
This document summarizes a presentation on Quality by Design (QbD) given at the 44th International SFSTP Congress on June 6-7, 2012. It discusses key QbD concepts like the quality target product profile, critical quality attributes, design space, and control strategy. It provides examples of applying QbD for drug substances and products. The document also reviews regulatory guidance on QbD and tips for including a QbD approach in marketing authorization applications. Implementing QbD can help improve process understanding, monitoring, and control while reducing testing and facilitating continuous improvement and change management.
- The document discusses strategies for marketing multiple drug brands for the same indication without cannibalizing existing brands.
- It finds that introducing a new brand usually benefits companies through increased market share and reputation, though it can also cause product confusion.
- Companies minimize cannibalization most effectively by targeting different patient subtypes and aligning with thought leaders.
- Most companies market related products together as a franchise rather than separately, with efficacy often being the top differentiator between brands.
The document discusses Thermo Scientific's leadership in serving science through analytical instruments, equipment, reagents, software and services. It highlights the company's size and scale, unmatched capabilities, portfolio of leading brands, and mission to make the world healthier, cleaner and safer. Key strengths include global industry leadership, ability to continuously invest in growth opportunities through R&D, and an excellent track record of financial performance. New products are presented for applications such as sample preparation, analysis, and data interpretation.
V. L. Kanthachari Pusapati has nearly 20 years of experience in the pharmaceutical industry. He is currently the General Manager of Validation at Sun Pharma Industries, where he leads validation activities across all of Sun Pharma's manufacturing sites globally. Previously, he held roles such as Director of Quality Assurance Validation at Gland Pharma and Hospira Healthcare. He has extensive expertise in validation processes, computer system validation, and ensuring compliance with Good Manufacturing Practices and regulatory requirements.
NewLook International, Inc. Contractor Training Presentation discusses the specifics of concrete, how its made, how to prepare concrete, how to decorative concrete with concrete stains, and how to maintain concrete with NewLook's preparation products. Business development information, the available options within the decorative concrete industry and more are included in this comprehensive training program.
The document discusses decorative concrete techniques presented at the World of Concrete conference in January 2012. It features case studies and photos of various decorative concrete projects using techniques like stamped concrete, stains and dyes, polished concrete, and exposed aggregate. The projects include pool decks, patios, bridges, and more. Contractors from across the United States installed the projects using decorative concrete methods.
The document discusses concrete patios and their benefits. It notes that concrete patios are versatile and durable, and can be stamped or textured to resemble other materials like brick or stone at a lower cost. It provides examples of popular stamped patterns used in different regions and notes that stamped concrete allows homeowners to create unique outdoor spaces that blend with their homes and landscaping.
SQF Certification for Packaging Companies = Food Safety SuccessSCS Global Services
As the packaging industry gears up for SQF, industry members should be well acquainted with the rigors of the program as well as the opportunities it represents. This presentation describes the drivers for SQF in the food packaging industry, the requirements for becoming certified, as well as SQF training options for getting started.
This document discusses the use of industrial waste materials as partial replacements for cement in concrete. Some common industrial wastes that can be used include fly ash, red mud, microsilica, ground granulated blast furnace slag, rice husk ash, and metakaolin. Using these materials improves the performance of concrete while also providing environmental benefits such as reducing the use of raw materials and fossil fuels in cement production and diverting waste from landfills. The document reviews the effects of different waste materials on the properties of concrete such as workability, compressive strength, tensile strength, and modulus of elasticity.
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
BIO Windhover Pharmaceutical Strategic Alliances Conference April 2011Nathan White, CPC
This document summarizes a presentation on creating an optimal commercial reimbursement landscape for pharmaceutical products. The presentation discusses the complexities of proving value to payers in light of healthcare reform uncertainties and a changing regulatory environment. It provides two case studies on companies that failed to consider reimbursement challenges and offers lessons on strategic planning to meet regulatory and reimbursement needs. The goal is developing a clinical and regulatory strategy that ensures reimbursement resonance with payers and reduces patient access barriers.
This presentation details private label management programs. It is presented by Mérieux NutriSciences, the leading internationally accredited provider of food safety, quality and nutrition services.
In this presentation, viewers will learn about:
- Private Label Needs
- Private Label Services
- Private Label Managed Programs
- Private Label Experience
The document discusses the challenges of keeping up with changing due diligence requirements in the food processing industry. It notes that due diligence is a moving target due to evolving regulations, best practices, technology, and customer expectations. It recommends that companies establish cross-functional teams to regularly review and monitor due diligence requirements, ensure communication about due diligence throughout the organization, conduct third-party due diligence assessments, and develop improvement plans based on assessment findings. Doing so can provide benefits like increased brand protection, confidence in food safety programs, transparency, and preparedness for issues.
Getting Started with GFSI (For Manufacturers)TraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Meeting Description:
Being compliant with a Global Food Safety Initiative (GFSI) recognized scheme can be a business accelerator, but is also often viewed as a daunting task. It doesn’t need to be.
Join our webinar to learn about the impetus for creating the GFSI, its benefits, and basic steps to get you going on the process to becoming compliant.
Karil Kochenderfer, GFSI’s North American representative, will start with an overview of the Global Food Safety Initiative and its benefits.
John Kukoly, Director of BRC in the Americas, will then give a general overview of what is required to begin the compliancy process with any GFSI-compliant scheme relevant to food manufacturers and ingredient processors.
Topics to be addressed:
-Why certification to a GFSI scheme matters to you
-Considerations in choosing a scheme
-The audit process explained
-Best practices for successful implementation
-Poor practices to avoid
-Key areas to focus on in planning and implementation
The webinar will conclude with both Karil and John taking questions from the audience.
About the Global Food Safety Initiative:
The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, service providers associated with the food supply chain, international organizations, academia and government.
Strategies for Improving Auditor Competency on a Global Perspectivededmark
This document discusses strategies for improving auditor competency from a global perspective. It outlines SGS' global capabilities in terms of the number of qualified auditors they have for various certification standards. It emphasizes the importance of training, qualifications, and ongoing development for auditors. Specific strategies proposed include formal education, internal and industry training, participation in professional associations, and feedback processes. Key qualifications for auditors include experience, training, and adherence to standards for impartiality.
Everything You Need to Know About BRCGS Global Standards.pdfOFFICE
BRC Global Standards (formerly British Retail Consortium) is a leading global safety and quality certification program for food, packaging, storage, and distribution. BRCGS certification sets rigorous standards for the management of food safety, operational integrity, and product quality throughout the supply chain.
اثر تطبيق HACCP في الفنادق علي سلامة وصحة الغذاءHany Atef
Applying HACCP in hotels reduces food loss and improves food safety and health by establishing prerequisite programs like Standard Operating Procedures (SOPs). SOPs accurately describe essential job tasks and using SOP checklists helps ensure production steps are done correctly, resulting in fewer mistakes.
INTRODUCTION OF Good Manufacturing Practices(GMP) Certificate, AND IT’S REGIS...Rishabhparihar8
The document discusses Good Manufacturing Practices (GMP) certification. It explains that GMPs ensure products are produced to industry standards for food safety and quality. Obtaining GMP certification involves adopting standards, undergoing an audit by a third party, and receiving a certificate if standards are met. Certification demonstrates a company's commitment to quality and can help access more customers and markets.
This document provides an overview of quality initiatives in the pharmaceutical industry, including the FDA's Pharmaceutical Quality for the 21st Century initiative and quality tools like Six Sigma. It discusses key dimensions of the FDA's initiative like having a risk-based and science-based approach. The document also summarizes pharmaceutical product lifecycles, Process Analytical Technology (PAT), and how approaches like Six Sigma can help drive continuous improvement in quality.
The document provides information about a two-day event on food safety policy and innovation. Day one includes a Lean Six Sigma White Belt certification course that teaches process improvement concepts and tools. Day two focuses on new food safety policies, regulations, and innovative approaches organizations can take to ensure safety. Attendees will learn about detection standards, preventative controls, and how to stay ahead of government guidelines through proactive strategies. The event aims to help professionals address recent issues and comply with changes in a cost-effective manner.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical products as outlined by the World Health Organization (WHO). It provides definitions and explanations of key GMP concepts including quality assurance, quality management, and ensuring consistent production of pharmaceuticals according to appropriate quality standards. It also discusses WHO involvement in establishing GMP guidelines and differences between GMP and current Good Manufacturing Practice (cGMP). The document outlines basic GMP principles for quality management, sanitation, qualification and validation, complaints and recalls, and more. It emphasizes that quality failures can result in regulatory warnings, market withdrawals, supply disruptions, and loss of credibility with patients and regulators.
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
Mérieux NutriSciences provides laboratory testing, auditing, consulting and other services related to food safety and quality. They have a global network of facilities and have experienced significant growth over the last 5 years. Their new facility in Saudi Arabia will help clients in the Middle East and Africa regions assure food safety and quality across their supply chains through integrated solutions like testing, inspection and certification services. Food safety has become increasingly important to consumers, regulators and businesses operating in Saudi Arabia.
AmalMerge is a Malaysian consultancy company specializing in food safety, HALAL compliance, and food engineering services with a network of affiliate consultants. The company provides consultancy, training programs, and documentation services to assist food manufacturing clients in meeting standards for good manufacturing practices, HACCP, ISO, and HALAL certification. AmalMerge has a corporate office in Kuala Lumpur and affiliate partnerships throughout Southeast Asia and internationally.
Hazard Analysis Critical Control Points (HACCP) is defined to be the food detrimental elements major control points by the food and drug administrative agent. HACCP is composed as hazard analysis (HA) and critical control points (CCP).
This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses Pharmalink's history, capabilities, experience, and case studies. Pharmalink was founded in 1998 and works with 18 of the top 20 healthcare companies. They have offices globally and can provide regulatory assistance across the entire product lifecycle from non-clinical development to post-approval tasks. Case studies demonstrate experience with large, global projects involving compliance, mergers and acquisitions, and product licenses.
1. Pharmalink is a leading independent regulatory affairs specialist founded in 1998 with over 155 staff across offices in Europe, US, India, and Asia-Pacific.
2. They provide regulatory solutions and assistance for projects of any scale or duration across the product lifecycle for a range of client types including 18 of the top 20 healthcare companies.
3. Case studies show Pharmalink's ability to successfully manage large, long-term global regulatory compliance projects for top pharmaceutical companies, ensuring on-time delivery and sustainable compliance.
- Pharmalink is a leading independent regulatory affairs specialist founded in 1998 with over 155 staff across offices in Europe, US, India, and Asia-Pacific.
- They provide regulatory solutions and assistance for projects of any scale or duration across the product lifecycle for a range of client types including 18 of the top 20 healthcare companies.
- Case studies provided examples of large, long-term regulatory compliance projects Pharmalink successfully completed for major pharmaceutical companies, bringing hundreds of product licenses and dossiers into compliance through regulatory work.
This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses Pharmalink's capabilities and experience, including that it has over 155 staff and works with 18 of the top 20 healthcare companies. The document also presents 4 case studies of large regulatory projects Pharmalink has successfully completed for major pharmaceutical clients. These involved global compliance, product licensing, and mergers/acquisitions work. Finally, it notes Pharmalink's global regulatory expertise and additional translation capabilities.
2. Agenda
Overview of Goals and Objectives
Services offered
Value Matrix
Qualifications
Industry Challenges & Company Needs
Path Forward
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3. Goals and Objectives
Present Food Industry Solutions
Value Creation
Services offered and principals’ qualifications
Discover areas of need for Company
Identify potential overlap of qualifications and needs
Establish agreed upon Path Forward
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4. Value Matrix
CHALLENGES COMPANY NEEDS OFFERED SERVICES
Evaluation of outsourced production – Quality Plant evaluations US or International
& Food Safety HACCP Reviews & Verifications
Food Safety Audits
FOOD SAFETY Knowledge of pathogen control strategies Third party validations of interventions and CCPs
and technologies Management Briefings
Sourcing – Shelf Life Extension and reduction Analysis of current status
of shrinkage Presentation of available solutions
COST CONTROL Cost effectiveness of QA and Food Safety Supplier assessments
programs Food Safety program Review
Food Service operators cost issues Food Cost Management, Labor efficiency studies
Knowledge and understanding of Regulatory Workshop on FDA approvals for food industry
REGULATORY framework Workshop on International approvals for pathogen
COMPLIANCE interventions
HACCP training
Liability and safety concerns Employee training sessions
PRODUCT Food Safety Regulations
LIABILITY Intervention strategies
Frequently Asked Questions
Understanding of evolving concept First Time Sustainability Reports (GRI G3 Guidelines)
SUSTAINABILITY First time review of company or vendors Assess any area of your business from a Sustainability
perspective
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5. Food Safety Expertise
Pathogen Control in slaughter, further processing and RTE
facilities
Best Practices, HACCP
Plant Inspections and training
USDA interfacing
FDA approvals and International regulatory compliance
Plant Operations
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6. Food Service Operations
Client Liaison Training
Subsidy Expense Reduction
Operator P & L Improvement
Labor Efficiency Studies
Food Cost Management
Quality Assurance
Technology Solutions
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7. Sustainability
First Time Sustainability Reports
Triple Bottom Line Reporting: profits + planet + people
Sustainability Reporting according to GRI G3 Guidelines
Assess any area of your business from a Sustainability
perspective
Company Protection from green washing/green washing
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8. Industry Challenges
QUALITY CONTROL & FOOD SAFETY
Sourcing - Safety and quality of incoming raw materials
Knowledge and understanding of ever-changing Regulatory
framework
Knowledge of pathogen control strategies and technologies
Liability and safety concerns
Employee training
Status of HACCP plan and Best Management Practices
Preparing for Audits
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9. Industry Challenges
OUTSOURCED FOOD SERVICE OPERATIONS
Re-bid of food services contract
Operational Assessments
RFP’s, negotiations, performance based contract
Client (Facility Manager) liaison training
Is your contractor performing up to industry standard?
Strategies to improve contractor performance
Subsidy expense planning reduction
What is reasonable?
Profit & Loss improvement
Labor efficiency
Food cost control and waste reduction
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10. Industry Challenges
SELF-OPERATED FOOD SERVICE OPERATIONS
First time outsourcing of Food Services
Does outsourcing make sense for your operation?
RFP’s, negotiations, transition, performance based contract
Contract (relationship manager) training
Is your contractor performing up to industry standard?
Strategies/tools to improve contractor performance
Profit & Loss improvement
Revenue drivers
Cost reduction programs
Labor efficiency
Productivity reviews
Food cost control and waste reduction
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11. Industry Challenges
SUSTAINABILITY
What is Sustainability Reporting and Green Practices
How do we realize tangible benefits from Sustainability
analysis and reporting
What is required today?
Where is this heading?
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12. Where next?
(and how do we get there?)
SUSTAINABILITY
Redevelop Value Matrix
Prioritize which concerns to focus on
Develop specific programs to address prioritized concerns
Agree on time table for implementation
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14. FIS Associates
Morten Blomso Anthony Morro Dr. Cayce Warf
A dynamic C-Level executive with over 15 yrs A proven leader in the corporate A respected scientist and research
developing and leading SME corporations dining industry, Anthony brings a expert holding a PhD in Chemistry
both internationally and domestically. unique perspective to FIS. and a MS in Physics.
Morten brings a successful track record in With deep knowledge of foodservice Diverse background in Sustainability
Operations, Business Development, Sales operations, retail, and vendor and Food Safety are essential to the
and Marketing, as well as Finance. management, he helps his clients core offerings of FIS.
improve all aspects of their dining
He is a respected Food Safety and program. Conversant in regulatory standards
Processing expert with deep strategic/ such as OSHA, USDA-FSIS, and
technical knowledge. Most recently Anthony headed up FDA as well as EPA and EU REACH.
an efficiency and quality program for
Sold and coordinated installation and start up a global food and facilities Cayce has a gift for processing
of Food Safety processes at food processing management organization where he complex data into understandable
plants in the US and abroad: Beef, Poultry, drove close to $2 million in savings insight and strategy for clients.
Pork, Produce, Seafood and RTE. per year. Active in several industry
Created Annual Sales Growth > 25% Prior to that he led the dining associations including the
managing large Corporate Accounts in multi- programs at Microsoft and Bristol International Association of Food
state territory 2006 – 2008. Myers Squibb over a 15 year period. Protection and Institute of Food
Technologist.
Managed and grew Global Aqua USA LLC, Originally from New York, Anthony
into the largest salmon farm in the USA. has lived in the Seattle area for 9 He and his wife Gail have lived in
years with his wife Loretta and 3 Woodinville for 10 years. He serves
Born in Norway, Morten lives with his wife
daughters. as an elder at the Woodinville church
and 3 children in the Seattle area where he is
of Christ.
active in the local community as a youth
soccer coach.
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