Predicting an instrument's performance over time is essential to the design phase. This session will cover reliability testing and performance deterioration, including recommendations for tests that should be performed to ensure that an instrument will function through a lifetime of use, and ways to collect measurable outputs of the instrument from initial use to the end of its lifecycle.
Predicting an instrument's performance over time is essential to the design phase. This session will cover reliability testing and performance deterioration, including recommendations for tests that should be performed to ensure that an instrument will function through a lifetime of use, and ways to collect measurable outputs of the instrument from initial use to the end of its lifecycle.
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Hiring For Advanced Quality Engineer in GurgaonSanjay Rajpoot
• Review quality assurance documentation to support mainly product sustenance and regulatory submissions or new product development related to line extensions/custom made devices.
• Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.
• Execute risk management activities for legacy care.
• Lead Quality Sustaining Engineering activities during legacy care activities of products to ensure the highest level of product and process quality. Provide guidance to R&D/Ops teams to ensure compliance to the company's quality system and external standards.
• Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development or legacy care process.
Email: sanjay@saracasolutions.com
CORE COMPETENCIES: Engineering / Project Management / Process Development
Accomplished professional with a long term distinguished track record of leadership, engineering and operations, with increasing responsibilities for functional management in all disciplines of manufacturing operations.
A history of success developing and managing operating budgets, departmental goal setting, spearheading new products along with process design and development, production line set-ups, product line transfers and implementing lean manufacturing processes. This includes manufacturing line optimizations and the coordination and supervision of multiple, diverse engineering projects and activities against tight deadlines.
Other responsibilities include project financial justifications, cost analysis, performance tracking, and evaluation of process enhancements pertaining to overall unit cost, quality and profitability. Consistently successful in improving quality, increasing production yields, and maximizing efficiency while making process improvements to reduce costs.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
1. TIMOTHY P. BURGE, BSME, MBA, CQE, CQA
3881 Zion Hill Rd
Weatherford, Texas 76088
Cell: 817-565-8883
Emails: timburge63@gmail.com, tim.burge@alconlabs.com
SUMMARY of QUALIFICATIONS
Recognized opinion leader with 30 years of medical device experience serving small and large
organizations. Proven ability to influence combined with agility to lead change throughout an
organization. Managed and directed employees to meet targets and exceed expectations. Proficient in
skill sets:
• FDA 21CFR820 and ISO 13485 Quality System Requirements
• Technical File and Design History File Development
• Quality Systems Development
• Lean Six Sigma
• Project Management
• Design and Manufacturing Quality Improvement
• Design Control CFR820.30 and Risk Management EN ISO 14971:2012
• Compliance Audits and External Interface with TUV and FDA
• Medical Device Single Audit Program (MDSAP)
• Supplier Quality
• Metrology
• Department Budgeting and Management
• Process Development
WORK EXPERIENCE
Alcon Laboratories (Novartis) Fort Worth, TX Research and Development Mar 2001-Present
Title: Manager, IOL Design Control and Principal Engineer
Currently direct 4 external contractors in support of compliance to new EU Medical Device Regulation
(EU)2017/745, developing Technical file content and Design History File content for 33 different
products including:
• Ophthalmic Viscoelastic Devices (OVD)
• Balanced Salt Solution (BSS)
• Tamponades for Retinal Surgery
• Intra-Ocular Lens (IOLs) Monofocal and Multifocal
• IOL Delivery Systems
• Custom Paks
• Incisional Instruments
• Non-absorbable Sutures
• Cannula Devices
• Contract Manufactured Devices
Responsible for compliance to design control requirements (21CFR820.30) for Intra-Ocular Lens(IOL)
related products including design reviews and deliverables, product surveillance to review product
2. performance and safety decisions in creation and maintenance of product risk management files. Led
risk management topic and discussion for internal/external audit interface as needed. Managed and
trained direct employees (team of 10) to coordinate design control and technical file activities. Led
teams to conduct non-conformance investigations, root cause analysis and corrective actions. Improve
and develop design control and risk management systems for product development process.
Key Accomplishments:
• 2019: Negotiated agreement with off shore account to support Alcon’s EU MDR compliance initiative
resulting in reduced cost with expedited results(FTW Products)
• 2018: Developed digital DHF process for Alcon Surgical(FTW Products)
• 2017: Alcon Cross Divisional Project- Led the Global Regulatory Affairs team in support of EU MDR to
develop a technical file consolidation process
• 2017: Received Technical Excellence team award for Growth and Innovation- Japan Return to Market
project
• 2001-2016: Implemented multiple IT systems in IOL R&D such as JDEdwards, CATSWEB, Calibration
Manager, and Windchill PLM
• 2016: Nominated and confirmed as Novartis Certified Investigator
• 2016: Created role based training process in IOL
• 2009-2015: Served as the Alcon Subject Matter Expert for Risk Management
• 2015: Trained in expert level Lean Six Sigma through Alcon Operational Excellence
• 2012: Alcon Global Project- Led Alcon’s functional management teams to harmonize the Risk
Management Process across all Alcon medical device divisions
• 2013: Presented device design and development process representing Alcon at Parenteral Drug
Association (PDA), Austin TX
• 2009: Managed R&D technical file team and reduced cycle time for technical file completion
Alcon Laboratories (Novartis) Fort Worth, TX Manufacturing May 1999-Mar 2001
Title: Supplier Quality Assurance Engineer
Responsible for all Fort Worth manufacturing sites (Fort Worth North and ASPEX) secondary packaging
vendor quality. Activities included on-site audits of Suppliers’ Quality Assurance systems, preparation of
standard purchase descriptions and requirements for acceptance, disposition of discrepant material
through material-review-board decisions and development of process validation documents to ensure
effective change control for secondary packaging components.
Cardinal Healthcare (Formerly Baxter International) Jacksonville, TX May 1994 - May 1999
Title: Sr Quality Engineer
Responsible for project management, leadership team for suction canister products, supervise hourly
personnel, nonconforming material disposition, and assist plant management in quality system
maintenance.
Key Accomplishments:
• Promoted to Sr Quality Engineer in 1997
• Installed automated vision system in support of lid assembly product design and process changes.
Vision system development supported the cost savings of an estimated $400K for product design and
manufacturing changes.
• Re-engineered the documentation process for product inspections.
3. • Installed automated vision inspection system equipment in-line with canister production.
• Assisted in plant implementation of Baxter Six Sigma Program.
Surgimedics, Inc The Woodlands, TX Aug 1991 - May 1994
Title: Quality Engineer
Responsible for project management, supervise hourly personnel, process validation, supplier quality
assurance, complaint analysis, and design control for blood collection devices and Custom tubing packs
for Open Heart By-Pass surgery.
Key Accomplishments:
• Interface with FDA. Optimized and documented the sterile packaging process in response to FDA
warning letter.
• Served as Design Control Engineer and Manufacturing Quality Engineer for all new products.
Bristol Myers-Squibb (Argon Facility) Athens, TX Aug 1988 - July 1991
Title: Quality Engineer
Responsible for metrology program, supervise hourly personnel, product qualifications, and design
control.
Key Accomplishments:
• Implemented the facility calibration system
• Led project team to optimize new product Catheter Lab Introducer through Design of Experiments
resulting in increased product confidence and sales.
Mar-Tech Automation and Control Lake Charles, LA Jan 1987 - Aug 1988
Title: Lab Supervisor
Responsible for general engineering duties, supervise hourly personnel, and author calibration
procedures
Key Accomplishments:
• Designed Jack Tester for Boeing
EDUCATION
• McNeese State University- Lake Charles , LA BS Mechanical Engineering May 1986
• Texas Christian University – Fort Worth , TX MBA Aug 2006
ACCREDITATION/CERTIFICATION
• Completed Lean Six Sigma Expert(Black Belt) Training through Alcon
• ASQ: Certified Quality Engineer (# 29121), Certified Quality Auditor (# 15461)
• SIX SIGMA: Baxter Certified Six Sigma Engineer 1996
REFERENCES
• Greg Williams, Head of GCA Audit for Novartis phone # 862-217-1404
