Pharmi Med Ltd is a consultancy firm that provides a variety of quality management, regulatory, and validation services for medical device and pharmaceutical companies. This includes helping companies establish quality management systems, obtain regulatory approval, conduct audits, and validate processes. The firm aims to be a one-stop solution for ensuring medical devices are approved for sale in target markets. It also provides templates and documentation to help clients become compliant more efficiently.
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
siddhartha consultancy services
www.scsuniversal.com
HR Consulting
Competency Mapping
Assessment Center
Mentoring
Performance Evaluation and Linking
with Reward Systems
Designing HR Processes
HR Outsourcing
Training Need Analysis
Training Evaluation
Psychometric Testing
Personality Profiling
Individual, Team and Organizational Tests
Organizational Survey
Recruitment for National and Overseas
Skills and Competency based selection
Competency Assessment for short listed candidates to fulfill the exact needs of jobs
Training Programmes at SCS
Managerial Skills
Communication Skills
Presentation Skills
Team Building
Leadership
Emotional intelligence
Time and Task Management
Creativity and Problem Solving
Analytical Thinking and Decision Making
Soft skill training for management trainees
Stress Management
HR for Line Managers
Interviewing Skills
Mentoring and Coaching
Counseling
Competency Mapping
Psychometric Testing
ISO 9001 /- Quality Management System
ISO 14001 - /Environment Management System
OHSAS 18001 - /Occupational Health & Safety
ISO 22000 / HACCP / BRC - /Food Safety Management
ISO 27001 - /Information security Management System
Software Management , Risk Assessment/ Design Management, Audit Services
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Regulatory Services: CTD/NTA to eCTD, Product Life-cycle Management (Renewal and Variation), Country specific Dossiers, Device master File, PV system, Patent (searching, drafting, filing), Technology transfer etc.
Call me for further discussion: +91-8800520825//9264127040
mail: reg.medwisdom@gmail.com
website: www.medwisdom.in
Pharmaceutical qualification and validations trainingMarcep Inc.
INTRODUCTION
This summit outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacturing of any pharmaceutical product, including APIs or drug item, referred to in this training summit as drugs. This training summit incorporates principles and approaches that all pharmaceutical manufacturers can use to validate manufacturing processes in their respective organizations
after attending the course.
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
Medwisdom services include Gap Analysis, Due Diligence, Crisis Avoidance, Formulation Development, Technology Transfer, Intellectual Property, Technical Dossier Preparation, Company Registration, Medical Devices, Training, Gxp Audit, Facilitate In Import/export
siddhartha consultancy services
www.scsuniversal.com
HR Consulting
Competency Mapping
Assessment Center
Mentoring
Performance Evaluation and Linking
with Reward Systems
Designing HR Processes
HR Outsourcing
Training Need Analysis
Training Evaluation
Psychometric Testing
Personality Profiling
Individual, Team and Organizational Tests
Organizational Survey
Recruitment for National and Overseas
Skills and Competency based selection
Competency Assessment for short listed candidates to fulfill the exact needs of jobs
Training Programmes at SCS
Managerial Skills
Communication Skills
Presentation Skills
Team Building
Leadership
Emotional intelligence
Time and Task Management
Creativity and Problem Solving
Analytical Thinking and Decision Making
Soft skill training for management trainees
Stress Management
HR for Line Managers
Interviewing Skills
Mentoring and Coaching
Counseling
Competency Mapping
Psychometric Testing
ISO 9001 /- Quality Management System
ISO 14001 - /Environment Management System
OHSAS 18001 - /Occupational Health & Safety
ISO 22000 / HACCP / BRC - /Food Safety Management
ISO 27001 - /Information security Management System
Software Management , Risk Assessment/ Design Management, Audit Services
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Regulatory Services: CTD/NTA to eCTD, Product Life-cycle Management (Renewal and Variation), Country specific Dossiers, Device master File, PV system, Patent (searching, drafting, filing), Technology transfer etc.
Call me for further discussion: +91-8800520825//9264127040
mail: reg.medwisdom@gmail.com
website: www.medwisdom.in
Pharmaceutical qualification and validations trainingMarcep Inc.
INTRODUCTION
This summit outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacturing of any pharmaceutical product, including APIs or drug item, referred to in this training summit as drugs. This training summit incorporates principles and approaches that all pharmaceutical manufacturers can use to validate manufacturing processes in their respective organizations
after attending the course.
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
Medwisdom services include Gap Analysis, Due Diligence, Crisis Avoidance, Formulation Development, Technology Transfer, Intellectual Property, Technical Dossier Preparation, Company Registration, Medical Devices, Training, Gxp Audit, Facilitate In Import/export
GMP Certification in Oman.GMP means Great Manufacturing Technique. It is a system for ensuring that products are regularly produced as well as managed according to high quality criteria. It is designed to reduce the threats involved in any pharmaceutical production that can not be gotten rid of through checking the final product.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
ISO 13485 Certification Everything You Need to Know.pdfOFFICE
ISO 13485 is a globally accepted standard designed to help medical device manufacturers maintain and continuously improve their quality management systems. It outlines the requirements for a comprehensive quality management system, covering every aspect from product development to manufacturing and post-market surveillance. This standard ensures that medical devices meet regulatory requirements and maintain the highest level of safety and efficacy.
ISO 13485 Certification: Benefits for Your Medical Device CompanyOFFICE
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Medical device QMS. A medical device is a product, such as an instrument, machine, implant or in vitro reagent that is intended for use in the diagnosis, prevention and treatment of diseases, rehabilitation of illness and disease or other medical conditions. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
What is good manufacturing practice gmp certificate and what is a benefits of...Rishabhparihar8
GMP Certification is of immense importance in the supplement industry as it is today, but it can be a long and expensive process, especially if you are entering the industry.
*If You have any doubt feel free to contact Corpseed Pvt.*
The ISO 13485:2016 standard governs quality management for medical devices and related services. It’s published by the International Organization for Standardization (ISO).
Get a free ISO 13485 quote from NQA today here: https://www.nqa.com/en-gb/certification/standards/iso-13485
Regulatory 101 for Medical Device Start UpsEMMAIntl
In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
What are the steps for ISO 13485 certificationhimalya sharma
Step by step approach defined to for attaining ISO 13485 Certification. You can achieve ISO 13485 Certification for your Organization by following these steps and learning support from the Specialist Industry Experts Principal Auditors
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
1. • Validation
• Quality Management System & CE Marking
• Regulatory Services
• Auditing Services
• Risk Management
• Design Control
• Audit Remediation
• Our Medical Device support
services cover Class I, II and III
Pharmi Med Ltd is a consultancy firm which believes in long term
partnership. We support short term, medium term and long term
project work for small-medium sized businesses, as well as large
corporations which may have a shortage in a skill or wish to
outsource work to improve productivity.
We help companies establish quality management systems (QMS)
which are compliant with medical device industry standards. We
also provide guidance where regulatory requirements can be
overwhelming and confusing. Pharmi Med Ltd is a one stop solution
for ensuring that your company’s medical devices are firmly on
track for being approved for sale in target markets. The following
are some of the services we can provide to your company:
Who We Are / Services
2. Concept to Market
Development of a new product
Phase I
Initiation Opportunity and Risk
Analysis
Phase II
Formulation Concept and
Feasibility
Phase III
Design and Development /
Verification & Validation
Phase IV
Final Validation/ Product Launch
Preparation
Phase V
Product Launch and Post Launch
Assessment
Financial Review
Market Analysis
Competitive
Assessment
Early Risk
Assessment
Legal/IP Analysis
and Filings
Regulatory and
Clinical Path
R&D
Pharmi Med
Ltd
Operations.
Project
Core
Team
Project
Plan and
Timeline
Customer
Input/
Voice of
Customer
Customer
Prototype
Evaluation
Early
Concept/
Selection
Prototype
Analysis
Initiate and
Maintain
Design
History File
(DHF)
Initiate
Design Risk
Analysis
(dFMEA)
IP Landscape
Review & review
of Filing
Initial Regulatory
Strategy
Initial
Reimbursement
Strategy
Initiate DFM
(Tooling, Fixturing)
Customer
Prototype
Evaluation
Product
Design
Development
Design
Verification
and Validation
Maintain DHF
and Project
Timeline
Design Risk
Analysis
(dFMEA)
Patent Review
Regulatory
Strategy
Update
Regulatory
Submission
Begin IQ/OQ/
PQ Validation
Clinical
Validation
Plan
Product
Branding
Market
Launch
Plan/
Forecast
Marketing/
Sales
DHF
Completion
dFMEA
Update and
Review
Design
Outputs
&Inputs
Final Patent
Review with R&D
Obtain
Regulatory
Clearance
Finalise
Reimbursement
Strategy
Mfg/Ops Scale
Up
Full Process
Qualification
Final Process
IQ/OQ/PQ
Physician
Training
and Sales
efforts
Post Market
Surveillance
Update
Reimbursement
as needed
Process
Improvements
as needed
Update Design
Docs as
needed
Quality Audits
Other
Departments
3. Design and Development
Industry Requirements & Validation
After conceptualising a new medical device, the next step in product
development is the design. This is the most important stage in the
development of a medical device since a flawed design may lead to
it being ineffective or unsafe. At the design stage, a design control
process needs to be initiated and implemented as part of the quality
system requirement.
At Pharmi Med Ltd we can complete documentation from start to
finish or support to meet requirements for FDA 21 CFR part 820.30,
and ISO 13485 clause 7.3:
• DESIGN AND DEVELOPMENT PLANNING
• DESIGN INPUT
• DESIGN OUTPUT
• DESIGN REVIEW
• DEVICE MASTER RECORD (DMR)
• DESIGN HISTORY FILE (DHF)
• TECHNICAL FILE (TF)
• DESIGN CHANGES
• DESIGN TRANSFER
• DESIGN VALIDATION
• DESIGN VERIFICATION
Pharmi Med Ltd can
assist in the compilation and
organisation of your DHF/DMR
or Technical File. We can support in
these activities for new products,
remediation for FDA clearance or
CE Marking. We will simplify the
entire submission process
4. Pharmi Med Limited will help you remain compliant with the
regulations. In the context of the Pharmaceutical and Medical
Device industries, validation is a process that businesses must
invoke throughout their company to ensure meeting the regulatory
requirements prior to market launch. It is the manufacturer’s
responsibility to ensure that there is adequate validation of all
processes involved in the production of any of these products. We
cater for equipment, cleaning and process validation.
Validating a process from beginning to end is a daunting task which
can involve an entire trail of quality assurance, not only of the
equipment involved in the production of your product, but also storage
conditions. Process Validation should verify that procedures and
processes, used in the manufacturing of your product, are suitable for
their purposes and guarantee that the process used will consistently
meet its predetermined specifications and quality characteristics. The
procedure must outline the way of carrying out an activity. The process
is a set of methods and actions which interact to convert what goes in
to what comes out.
In the context of the
Pharmaceutical and Medical Device
industries, validation is a process that
businesses must invoke throughout their
company to ensure meeting the
regulatory requirements prior
to market launch.
Validation
5. Pharmi Med Ltd is a one stop solution for medical devices
which covers guidance for European requirements for CE
marking using Medical Device Directive 93/42 EEC, In Vitro
Medial Device Directive 98/79 EC, FDA requirements for
United States, as well as ROW (Rest of World). Our concept to
market graphic explains the stages where we will help you.
Our support includes knowledge of the appropriate standards
and several product specific standards.
Our Medical Device support services cover Class I, II and III
Medical Device Documentation Support
Pharmi Med
can help from set up,
to assistance with new
product development, to
ongoing validation and
regulatory, and remediation
work from audits. We can
also help you with a
Gap Analysis
6. • SOP Write Up
• Setting up Quality Management Systems or
Review of Quality Documentation
• Validation
• Laboratory Setup
• Cleanroom Setup
• Facility Setup/New or Modified Production Lines.
We can support combination devices which include the
requirements of both medical devices and pharmaceutical
regulations, as well as herbal/supplementary products which
may require GMP.
Pharmi Med Ltd has supported many pharmaceutical companies,
including start-up businesses, to meet cGMP (current good
manufacturing practises), Eudralex Annex 15 and MHRA
requirements, including FDA part 210 and 211. We also use the
latest PIC/S (Pharmaceutical Inspection Cooperation Scheme)
guidelines and GAMP (Good Automated Manufacturing Practice)
methods.
Our pharmaceutical documentation support includes many of the
services listed in the services section, including (but not limited
to) –
Pharmaceutical Documentation Support
Pharmi-Med Ltd will
achieve GMP requirements of
"establishing documented evidence
that establishes a high degree of
certainty that a particular process
will consistently produce a product
that provides the previously
established specifications
and quality attributes
are available."
7. Our regulatory expertise can help you:
• US Requirements:
• Pre-Market Notification — 510(k)
• Pre-Market Approval — PMA
• Combination Product (drug/device) Submissions
• Establishment Registration and Device Listing
• European Requirements
• Technical File, Design Dossier Preparation
• Clinical Evaluations
• CE Mark Facilitation
• SO 13485 Audits for Medical Device Companies
Medical device manufacturers must regularly conduct an audit of their ISO
13485 compliant quality management system. We can perform independent
quality system reviews for companies that are already ISO 13485 certified. We
can also help companies who are about to have their initial ISO 13485
certification audit by a notified body.
Pharmi Med Ltd. offer the following ISO 13485 auditor services:
ISO 13485 audits help to determine the actual status of your current quality
management system and processes. Pharmi Med Ltd offer the following ISO
13485 auditor services:
Off-site review of your current QA/RA documentation prior to your on-site ISO
13485 audit by a notified body. Review of your internal documentation to verify
that requirements have been addressed actual verification of ISO 13485 audit
requirements through review of objective evidence evaluation of current special
controls or validated processes; knowledgeable in various processes.
Additional ISO 13485 Audit Services
You can also contract us to conduct targeted ISO 13485 process audits in which
we focus on specific areas where noncompliance issues have occurred, or on
areas your internal auditors cannot audit due to conflicts of interest.
We can also implement ISO 9001 Quality
Management Systems. Please contact us
for more information on our ISO 13485
and ISO 9001 auditing service
We can do an off-site
review of your current
QA/RA documentation
prior to your on-site
ISO 13485 audit
Auditing and Regulatory Services
Regulatory requirements for medical devices can be very daunting without the
correct knowledge and experience. Understanding regulatory requirements for
each geographical agency can have its own challenges and lengthy processes.
8. Greenlight Guru – The Software
Pharmi Med Ltd have teamed up with Greenlight Guru, a
specialised electronic Quality Management System platform
which is specifically designed for medical devices. Pharmi
Med Ltd will work with your medical device company to get
you on the path to regulatory compliance in partnership
with Greenlight Guru, a web based system that is easy and
practical to use and will minimise your paper trail and
consequently your need for excessive consultant hours,
allowing you to focus on your product and getting it to
market. Greenlight Guru and Pharmi Med Ltd are both well
equipped with the specialised expertise and know-how to
get your device to market, and most importantly – STAY in
the market!
An entirely new way to manage your quality and compliance
The Greenlight Guru Story
The seeds for Greenlight Guru were planted back in 2006 by a
medical device engineer turned consultant as a result of a
simple observation; paper-based quality management systems
are painful, risky & wildly inefficient. Commercial quality
management software solutions have been available for over
20 years, yet only about 30% of medical device companies that
should be using them are. But why?
This observation and question led Jon Speer to team up with
David DeRam to create the vision for a beautifully simple
quality management software, which became the Greenlight
Guru platform. With our powerful, easy to use eQMS solution,
medical device companies can bring higher quality life
changing devices to market, faster – which, after all, is our
mission.
Design Control
9. At Pharmi Med Ltd we have invested our time to develop easy to use templates
for your business. This could save you thousands of pounds in consultancy fees
by utilising pre-populated templates for validation and compliance requirements.
All you have to do is simply pay and download your template and we will be
available for any online guidance in helping you populate your templates. Here
you will be able to preview part of the document, purchase and download a
complete editable Microsoft Word version.
Pharmi Med Ltd offers these tried and tested templates throughout the
Pharmaceutical and Medical Device Industry. We offer tailored services for
bespoke requirements such as validation for water, specific packaging
equipment, your facility, specific laboratory equipment, Standard Operating
Procedures, Risk Management and Design Control.
Please Contact Us With Your Exact Requirements
Downloadable Templates