Cpo cmo serialization back to school

•

1 like•786 views

Contract packagers and contract manufacturers have unique challenges when serializing product for the pharmaceutical industry. Michael Stewart, of PharmTech, covers the regulations and project management concerns CMO's and CPO's should address.

Health & Medicine

SchoolSerialization for Pharma CMO/CPO’s
Back to
How to survive and thrive in the era of serialization

Agenda
 Introduction
 Today
 Challenges
 Solutions
 Next Steps

PharmTech Inc.
Serving FDA regulated industries since 1995
Involved in Track & Trace since 2005.
Working with a Top 10 Pharma Co. and Virtual Manufacturer
Industry speaker at conferences, webinars and author of
white papers on e-Pedigree/ serialization
in pharmaceuticals.
Diversified Team Skills;
• IT Integration
• Quality Management
• Distribution
• Serialization
• Line Integration (Packaging & Manufacturing)
• GS1 Standards

PharmTech Project List
• Evaluating solutions providers
• Implementing GS1 Standards
• Piloting for serialized product and trades
• Long-range planning & Impact analysis
• Serialized data share and systems interoperability
• Revising strategy in response to legislation
• Trading partner connection (CMO and CPO to Client)

Today
Regulator Perception vs. CMO/CPO Reality

Perception - Simple
Customer
Order
CMO/CPO
Make/Package
Customer
Receive/Ship
Wholesaler
RX

Reality
CMO
CPO
Mfr
A Mfr
B
Mfr
C
Mfr
D
Mfr
E
Mfr
F
Mfr
G
Mnf
H
Mfr I
Mfr J
Mfr
K

State of the (Pharma) Industry
Serialization Stage*
Evaluating
Strategy/Providers
Small Pilot
Multi Site Roll Out
Not Started
*IQPC “Pharmaceutical Serialisation and
Traceability Survey”, 2012

CMO/CPO Challenges
 Regulatory timelines
 Regulatory uncertainty
 Conflicting demands
 Lack of visibility
beyond own walls
 Evolving standards
 Serialization solutions are
system specific
 Meeting multiple
customer requirements

Moving Forward
“A project well planned is a project already half done well.”

Tackling the Challenges
Be proactive
Develop strategy and a LRP
Identify ROI and Business Value, in advance
Define a core solution
Conduct a Gap Analysis

5 Point Solution
A core system that is;
 Flexible and scaleable
 Standards based
 Integration compatible with multiple enterprise
 Validation compatibility
 Leverages existing infrastructure

Why a 5 Point Solution?
Business Value;
 First mover advantage- let clients connect to you
 Scale with company and client growth
 Standardization adjusts to new customer and regulatory
mandates
 Not if, but when
Reduce integration costs

Next Steps…
• Conduct a Gap Analysis
• Map all relevant processes
• Identify all work areas effected
• Discover efficiencies from automation
• Gather business requirements
• From customers (their needs and requirements)
• Internally
• Conduct an independent vendor assessment

How can PharmTech help?
Michael Stewart
mstewart@pharmtechinc.com
(847) 281-8924 Office
(815) 403-8425 Cell

Pharmaceutical serialization en mass will occur in 2013 due to US and es-US regulations to track products at the item level. Michael Stewart of PharmTech Inc. shares his insight into the project Management pitfalls and allows you to use his learning curve working with top 10 pharmaceutical manufacturers, contract manufacturers and virtual manufactures to get ROI and business value in addition to compliance. Turn a perceived cost into an investment.

Attilio Bellman - ISPE - Pharma Expo Seminar Presentation_Oct_06_2015Attilio Bellman

SAP Advanced Track and Trace

Ryan Sonnenberg

IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes. While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements. In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.

Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...

Greenlight Guru

The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation. SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

How to Comply with IDMP Regulatory Requirements

Perficient, Inc.

The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57. The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines." Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project. Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline: -Latest information and timelines -Steps to take meet regulatory requirements -Challenges and factors to consider -What IDMP means in the real world of a typical pharma company

Description & functions of drug regulatory affairs

Cepal & Co.

Life Sciences Executive Overview

Ryan Sonnenberg

Life sciences companies are in a complex market where healthcare costs have risen rapidly while reimbursements and margins have fallen to new lows. New genomic and large-molecule innovations are transforming therapies and improving patient outcomes. Targeted treatments for individuals with similar genetic markers continue to advance quickly. New collaboration models across partners, providers, and patients reinforce this trend.

Program Regulatory Affairs by IBRI Noida

IBRI Noida

Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...

Torben Haagh

Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015. There are limited places available, so make sure you secure your conference ticket today! Learn more here. Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from: • Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more. Want to know more regarding this topic area? Then join us at our IDMP Implementation - Impact on Data, Systems and Processes 24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany For more information take a look at our agenda here: http://bit.ly/IDMP_agenda Or visit our website: http://bit.ly/IDMP_website

IDMP and RIM: friend or foe?eCTDconsultancy

Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017

April Bright

Keeping a finger on the pulse of regulatory changes taking place worldwide is hard to do, but nonetheless imperative. This presentation will provide a high-level overview of the more significant global regulatory changes that will impact orthopaedic manufacturers in the next two years. These include European Medical Device Regulation, ISO 13485:2016, MDSAP and U.S. FDA changes, as well as other global topics of interest. Ms. Loh, who leads the regulatory team at EMERGO, returned to OMTEC to provide perspective on strategies and risks to consider with these wide-ranging and sometimes overlapping matters. This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.

Using the new OTC guidance to help compile a successful application

TGA Australia

How to Review, Cleanse, and Transform Clinical Data in Oracle InForm

Perficient, Inc.

When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster. During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.

IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...

Torben Haagh

ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead! Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information: # Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site! # Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma # Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies # Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals! For more information visit our website: http://bit.ly/EventWebsite If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event

TGA Presentation: GMP Clearance Information Session,5-7 September 2017

TGA Australia

Presentation: Revision of the Uniform Recall Procedure for Therapeutic Goods ...

TGA Australia

Regulatory affairs.

Naila Kanwal

Strategies for Device Approval in China, India, South Korea and Australia

April Bright

This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.

Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...

April Bright

Infographic: Guide to Pharma Serialization

Shikha Saxena

IT Compliance Consultant & Computer Systems Validation Consultant

Andrea Giampellegrini

An engineering based Computer Systems Validation Consultant with extensive Pharmaceutical and Medical Device industry experience (Manufacturing, R&D, IT and QC/QA departments) in a wide range of GxP projects. FDA and EU GxP Regulations. GAMP 5 methodology. Experience in providing QA-support, project management and execution of validation & compliance projects for various computerized systems. Data Center, IT Infrastructures, ERP, EDMS, MES, Dispensing System, DCS, SCADA, PLC, Machinery, HVAC, LIMS, CDS, SAS, Laboratory instruments, Spreadsheets, Databases, Warehouses Management System, BarCode/Rfid System.

What's hot

Serialisation be4ward inc

Be4ward

Best Practices in the Field of Serialization and Safe Supply Chain

László Árvai

Case Study: Pharmaceutical Track And Trace System in Turkey

İlaç Takip Sistemi (İTS)

Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance

Perficient, Inc.

Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...

Greenlight Guru

How to Comply with IDMP Regulatory Requirements

Perficient, Inc.

Description & functions of drug regulatory affairs

Cepal & Co.

Life Sciences Executive Overview

Ryan Sonnenberg

Program Regulatory Affairs by IBRI Noida

IBRI Noida

Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...

Torben Haagh

IDMP and RIM: friend or foe?eCTDconsultancy

Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017

April Bright

Using the new OTC guidance to help compile a successful application

TGA Australia

How to Review, Cleanse, and Transform Clinical Data in Oracle InForm

Perficient, Inc.

IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...

Torben Haagh

TGA Presentation: GMP Clearance Information Session,5-7 September 2017

TGA Australia

Presentation: Revision of the Uniform Recall Procedure for Therapeutic Goods ...

TGA Australia

Regulatory affairs.

Naila Kanwal

Strategies for Device Approval in China, India, South Korea and Australia

April Bright

Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...

April Bright

What's hot (20)

Serialisation be4ward inc

Best Practices in the Field of Serialization and Safe Supply Chain

Case Study: Pharmaceutical Track And Trace System in Turkey

Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance

Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...

How to Comply with IDMP Regulatory Requirements

Description & functions of drug regulatory affairs

Life Sciences Executive Overview

Program Regulatory Affairs by IBRI Noida

Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...

IDMP and RIM: friend or foe?

Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017

Using the new OTC guidance to help compile a successful application

How to Review, Cleanse, and Transform Clinical Data in Oracle InForm

IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...

TGA Presentation: GMP Clearance Information Session,5-7 September 2017

Presentation: Revision of the Uniform Recall Procedure for Therapeutic Goods ...

Regulatory affairs.

Strategies for Device Approval in China, India, South Korea and Australia

Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...

Viewers also liked

Infographic: Guide to Pharma Serialization

Shikha Saxena

IT Compliance Consultant & Computer Systems Validation Consultant

Andrea Giampellegrini

Case Study: Pharmaceutical Track And Trace System in Turkey

Nart Bilişim Hizmetleri - TechNarts

GMP's as per US FDA : Part E

GMP EDUCATION : Not for Profit Organization

GMP's as per US FDA : Part A

GMP EDUCATION : Not for Profit Organization

New EU Requirements for Qualification & Validation

GMP EDUCATION : Not for Profit Organization

This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account. Highlights of the guidance are given in following presentation.

Correlation of FDA-EU-PICS-WHO Requirement for Computer System Validation

GMP EDUCATION : Not for Profit Organization

Sampling of pharmaceuticals

GMP EDUCATION : Not for Profit Organization

Risk Assessment for Control of Elemental Impurities.

GMP EDUCATION : Not for Profit Organization

Concept of URS,DQ,IQ,OQ,PQ

dhavalrock24

Viewers also liked (10)

Infographic: Guide to Pharma Serialization

IT Compliance Consultant & Computer Systems Validation Consultant

Case Study: Pharmaceutical Track And Trace System in Turkey

GMP's as per US FDA : Part E

GMP's as per US FDA : Part A

New EU Requirements for Qualification & Validation

Correlation of FDA-EU-PICS-WHO Requirement for Computer System Validation

Sampling of pharmaceuticals

Risk Assessment for Control of Elemental Impurities.

Concept of URS,DQ,IQ,OQ,PQ

Similar to Cpo cmo serialization back to school

Proven Movilitas Process #3 - Requirements & Processes

Stefan Hockenberger

Gain Faster Closure, Lower Risk and Better Results with IBM Emptoris

Perficient, Inc.

Procurement organizations are often challenged with lack of spend visibility, little-to-no automation around sourcing processes, difficulties in on-boarding, registering and measuring performance, and more. These organizations need to not only show value to the enterprise by reducing costs, but also provide value-added services to the business. Sarah Radka, senior business consultant in Perficient’s IBM industry solutions practice, demonstrates how a leading international producer and marketer of beer, wine and spirits improved efficiency in the contract process by implementing a full IBM Emptoris solution. During this webinar, our solution experts covered the keys to addressing critical contracting and supplier issues such as: Streamlining procurement operations and removing bottlenecks Providing and increasing overall spend visibility for an entire organization Rationalizing and consolidating all templates into a standardized subset Improving performance, attaining cost savings, mitigating risks and more

Pharm tech core traceability presentationMichael Stewart

Stabicon Outsourcing PresentationStabicon123

Qumas Collaboration to Innovation Quality QMS PIMS 2014

GBX Summits

Three steps-to-selecting-a-plm-system-white-paper

CBX Software

There are a number of factors to consider when selecting a PLM system, including the return on investment, readiness of internal processes, scalability, integration, ease of use and more. For over 18 years, we have supported large brands and retailers such as Safeway, Kmart, Migros, Lidl, Carrefour and many others with product lifecycle management and related systems. Before you select a system or look at upgrading your current one, we hope you will have a look at our white paper on how to select a PLM system. Please visit our company website to have more information: http://www.coresolutions.com/ Or give us some comments: http://www.coresolutions.com/request-a-callback/

IntegrtdAppro-GlblSuppChnTrans-Final-v2aMark Hardison, CFPIM, CSCP

Wilson perumal operating model design

Wilson Perumal and Company

Zero Wait-State Agile EC MCAD Implementation Quick Start Presentation

Zero Wait-State

2014-10-15 Agility Solution DF Session SlidesGeoff Rothman

Alineación de requerimientos y pruebas de software

Software Guru

No porque una aplicación esté libre de errores significa que cumple los requerimientos de la empresa. Para validar si ha satisfecho la necesidad empresarial, es necesario unificar los procesos de requerimientos y pruebas. En este taller mostraremos como se pueden priorizar las pruebas de acuerdo con las necesidades empresariales, para asegurar que nuestras aplicaciones están alineadas con los requerimientos del negocio. Estaremos utilizando las herramientas de Borland para gestión de requerimientos y pruebas, así que para aprovechar al máximo la sesión trae tu computadora portátil. Requerimientos de sistema: - Sistema operativo Windows (XP, Vista o 7) - Mínimo 2 GB de RAM - Deshabilitar User Access Control (UAC) Semblanza del conferencista: Rebeca Márquez es consultor senior en Borland – Micro Focus, empresa líder en herramientas para el ciclo de vida desarrollo de software. Rebeca cuenta con 9 años de experiencia como PMO y líder técnico en diversos proyectos de pruebas y monitoreo para el aseguramiento de la calidad y validación de sistemas en todas las fases del ciclo de vida de las aplicaciones para mercados como el bancario, telecomunicaciones, aseguradoras, financieras y retail principalmente.

Sabrion_Consulting_Overview CPG Retail Apparel.pdf

Brion Carroll (II)

Sabrion has a highly qualified team of retail/manufacturing process experts and IT consultants, supporting both short and long-term needs. Our FastForward implementation methodology to support PLM and Merchandise planning. Project Management PMI – Project Management Institute PMBOK – Project Management Body of Knowledge Agile – We utilize Agile, Scrum, and Extreme methodologies when appropriate We are flexible to embrace the methodologies used by our customers an business partners Retail/Manufacturing Business Process Re – Engineering As-Is and To-Be Modeling, SIPOC, RACI, Impact Analysis, Standard Operating Procedures Application Design, Development and Integration UML – Unified Modeling Language Open Internet and Standards, HTML5, CSS3, JQuery, Javascript, Web Frameworks Application Architecture Application Infrastructure Design – Virtualization, Cloud, Application Servers, Storage, Web DMZ Global Network Design – LAN, WAN, MPLS, Reverse Proxy, CDN Deployment Architecture – Dev, QA, Staging, Production

iGrafx | Business Process Management Solution Provider | ProServ UAE

ProServ

Services catalogue 2019

Matilde Beltrandi, PhD

We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price. Our broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.

Building a Complete View Across the Customer Experience on Oracle BICS

Shiv Bharti

Many organizations today are using a Modern Business Intelligence Platform or Big Data to eliminate Customer Blind Spots. When most firms refer to Big Data, they are not necessarily using “BIG” data, the term is used interchangeably with Analytics by most of our Customers. Organizations today are increasingly relying on Data to make strategic decisions. Marketing Departments are using Predictive analytics to identify the Prospects or segments that will give their firms the most “lift” and thus highest ROI. What are Customer Blind Spots? Gaps in your view of the customer relationship across time No formal social media listening data Lack of cross-device identity Inability for organizations to deliver personalized customer experiences Inability to apply predictive analytics to customer behavior to optimize products and services What are the Challenges to eliminate blind spots? Disparate Data sources Multiple Sources of the truth Growth in Data Volumes Data Migration Challenges Fundamental Considerations for a Customer 360 project Customer 360 project should focus on making substantial improvements in 5 key areas: Improve data quality, create Linkages across our various systems, centralize disparate information, transform the data to enable action and insights, and streamline the manner in which data is accessed and available. Each pillar contains a stream of work broken into parallel paths to accelerate the rollout and adoption of the platform. If you’re attending @Oracleopenworld (#oow16) and are considering a project to build a Customer 360-degree view by eliminating Customer Blind spots, please join us for our session to learn more on this subject including a customer case study. We look forward to a great session and stimulating conversations. Building a Complete View Across the Customer Experience on Oracle BI Cloud Service [CON3730] Monday, Sep 19, 4:15 p.m. – 5:00 p.m. | Moscone West – 2006

Knowledge acquisition group capabilities 2014 q1 (concise)

AnnettaColeman

Rapidflow apps agile pg&c solution

MBist

Company products need to comply with various standards, regulations or tracking guidelines to conduct business in any country. Compliance can slow down product launches into the desired markets and even act as a barrier to entry. Rapidflow’s preconfigured Agile PG&C solution allows integrating substance information that is relevant to substance regulation into the Agile Product Lifecycle Management system in record time that makes this information immediately available to engineering, manufacturing, purchasing, quality, sales, and regulatory personnel and thereby ensuring product compliance.

Dhaval Shah on "Strategic Alignment Of Projects For Higher Profits And Increa...

PMI Pearl City Chapter

EBook-ProcessvsProject-LLamasoftDavid Barron

EBook-ProcessvsProject-LLamasoftBob McFarland

Similar to Cpo cmo serialization back to school (20)

Proven Movilitas Process #3 - Requirements & Processes

Gain Faster Closure, Lower Risk and Better Results with IBM Emptoris

Pharm tech core traceability presentation

Stabicon Outsourcing Presentation

Qumas Collaboration to Innovation Quality QMS PIMS 2014

Three steps-to-selecting-a-plm-system-white-paper

IntegrtdAppro-GlblSuppChnTrans-Final-v2a

Wilson perumal operating model design

Zero Wait-State Agile EC MCAD Implementation Quick Start Presentation

2014-10-15 Agility Solution DF Session Slides

Alineación de requerimientos y pruebas de software

Sabrion_Consulting_Overview CPG Retail Apparel.pdf

iGrafx | Business Process Management Solution Provider | ProServ UAE

Services catalogue 2019

Building a Complete View Across the Customer Experience on Oracle BICS

Knowledge acquisition group capabilities 2014 q1 (concise)

Rapidflow apps agile pg&c solution

Dhaval Shah on "Strategic Alignment Of Projects For Higher Profits And Increa...

EBook-ProcessvsProject-LLamasoft

Recently uploaded

Physiology of Special Chemical Sensation of Taste

MedicoseAcademics

Title: Sense of Taste 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 structure and function of taste buds. Describe the relationship between the taste threshold and taste index of common substances. Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation. Recognize different abnormalities of taste perception and their causes. Key Topics: Significance of Taste Sensation: Differentiation between pleasant and harmful food Influence on behavior Selection of food based on metabolic needs Receptors of Taste: Taste buds on the tongue Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper) Primary and Secondary Taste Sensations: Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami Chemical basis and signal transduction mechanisms for each taste Taste Threshold and Index: Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine) Taste index relationship: Inversely proportional to taste threshold Taste Blindness: Inability to taste certain substances, particularly thiourea compounds Example: Phenylthiocarbamide Structure and Function of Taste Buds: Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers Location of Taste Buds: Found in papillae of the tongue (Fungiform, Circumvallate, Foliate) Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus Mechanism of Taste Stimulation: Interaction of taste substances with receptors on microvilli Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes Taste Sensitivity and Adaptation: Decrease in sensitivity with age Rapid adaptation of taste sensation Role of Saliva in Taste: Dissolution of tastants to reach receptors Washing away the stimulus Taste Preferences and Aversions: Mechanisms behind taste preference and aversion Influence of receptors and neural pathways Impact of Sensory Nerve Damage: Degeneration of taste buds if the sensory nerve fiber is cut Abnormalities of Taste Detection: Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia) Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels Neurotransmitters and Taste Threshold: Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity Supertasters: 25% of the population with heightened sensitivity to taste, especially bitterness Increased number of fungiform papillae

Maxilla, Mandible & Hyoid Bone & Clinical Correlations by Dr. RIG.pptx

Dr. Rabia Inam Gandapore

ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdf

Anujkumaranit

The Normal Electrocardiogram - Part I of II

MedicoseAcademics

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

ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx

Swetaba Besh

Charaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya

Dr KHALID B.M

heat stroke and heat exhaustion in children

SumeraAhmad5

Ophthalmology Clinical Tests for OSCE exam

KafrELShiekh University

Ocular injury ppt Upendra pal optometrist upums saifai etawah

pal078100

HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...

GL Anaacs

Contact us if you are interested: Email / Skype : kefaya1771@gmail.com Threema: PXHY5PDH New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH ! Contact me on Threema or skype to start big business!! Hot-sale products: NEW HOT EUTYLONE WHITE CRYSTAL!! 5cl-adba precursor (semi finished ) 5cl-adba raw materials ADBB precursor (semi finished ) ADBB raw materials APVP powder 5fadb/4f-adb Jwh018 / Jwh210 Eutylone crystal Protonitazene (hydrochloride) CAS: 119276-01-6 Flubrotizolam CAS: 57801-95-3 Metonitazene CAS: 14680-51-4 Payment terms: Western Union,MoneyGram,Bitcoin or USDT. Deliver Time: Usually 7-15days Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet. Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details. We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.

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.

ACUTE SCROTUM.....pdf. ACUTE SCROTAL CONDITIOND

DR SETH JOTHAM

Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum. There are a number of conditions that present acutely, predominantly with pain and/or swelling A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle. Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction. The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent

BRACHYTHERAPY OVERVIEW AND APPLICATORS

Krishan Murari

Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journey

greendigital

Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye. Follow us on: Pinterest Introduction Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing . Early Life and Career Childhood and Athletic Beginnings Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle. Transition to Acting Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness. Fitness Regimen Workout Routine Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show. Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles. Importance of Flexibility and Mobility In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit

Novas diretrizes da OMS para os cuidados perinatais de mais qualidade

Prof. Marcus Renato de Carvalho

Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva. Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade. Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal. Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural. Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis. É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais. O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada. Recomendamos muito. Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos. Esta publicação só está disponível em inglês até o momento. Prof. Marcus Renato de Carvalho www.agostodourado.com

Prix Galien International 2024 Forum Program

Levi Shapiro

June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels: - ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING - WOMEN’S HEALTH: FERTILITY PRESERVATION - WHAT’S NEW IN THE TREATMENT OF INFECTIOUS, ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES? - ARTIFICIAL INTELLIGENCE AND ETHICS - GENE THERAPY - BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE - ETHICAL CHALLENGES IN LIFE SCIENCES - Prix Galien International Awards Ceremony

Report Back from SGO 2024: What’s the Latest in Cervical Cancer?

bkling

Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.

Phone Us ❤85270-49040❤ #ℂall #gIRLS In Surat By Surat @ℂall @Girls Hotel With...

Savita Shen $i11

24 Upakrama.pptx class ppt useful in all

DrSathishMS1

Superficial & Deep Fascia of the NECK.pptx

Dr. Rabia Inam Gandapore

Recently uploaded (20)

Physiology of Special Chemical Sensation of Taste

Maxilla, Mandible & Hyoid Bone & Clinical Correlations by Dr. RIG.pptx

ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdf

The Normal Electrocardiogram - Part I of II

ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx

Charaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya

heat stroke and heat exhaustion in children

Ophthalmology Clinical Tests for OSCE exam

Ocular injury ppt Upendra pal optometrist upums saifai etawah

HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...

New Drug Discovery and Development .....

ACUTE SCROTUM.....pdf. ACUTE SCROTAL CONDITIOND

BRACHYTHERAPY OVERVIEW AND APPLICATORS

Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journey

Novas diretrizes da OMS para os cuidados perinatais de mais qualidade

Prix Galien International 2024 Forum Program

Report Back from SGO 2024: What’s the Latest in Cervical Cancer?

Phone Us ❤85270-49040❤ #ℂall #gIRLS In Surat By Surat @ℂall @Girls Hotel With...

24 Upakrama.pptx class ppt useful in all

Superficial & Deep Fascia of the NECK.pptx

Cpo cmo serialization back to school

1. SchoolSerialization for Pharma CMO/CPO’s Back to How to survive and thrive in the era of serialization

2. Anything new?

3. Agenda  Introduction  Today  Challenges  Solutions  Next Steps

4. PharmTech Inc. Serving FDA regulated industries since 1995 Involved in Track & Trace since 2005. Working with a Top 10 Pharma Co. and Virtual Manufacturer Industry speaker at conferences, webinars and author of white papers on e-Pedigree/ serialization in pharmaceuticals. Diversified Team Skills; • IT Integration • Quality Management • Distribution • Serialization • Line Integration (Packaging & Manufacturing) • GS1 Standards

5. PharmTech Project List • Evaluating solutions providers • Implementing GS1 Standards • Piloting for serialized product and trades • Long-range planning & Impact analysis • Serialized data share and systems interoperability • Revising strategy in response to legislation • Trading partner connection (CMO and CPO to Client)

6. Today Regulator Perception vs. CMO/CPO Reality

7. Global Regulations

8. Perception - Simple Customer Order CMO/CPO Make/Package Customer Receive/Ship Wholesaler RX

9. Reality CMO CPO Mfr A Mfr B Mfr C Mfr D Mfr E Mfr F Mfr G Mnf H Mfr I Mfr J Mfr K

10. State of the (Pharma) Industry Serialization Stage* Evaluating Strategy/Providers Small Pilot Multi Site Roll Out Not Started *IQPC “Pharmaceutical Serialisation and Traceability Survey”, 2012

11. CMO/CPO Challenges

12. CMO/CPO Challenges  Regulatory timelines  Regulatory uncertainty  Conflicting demands  Lack of visibility beyond own walls  Evolving standards  Serialization solutions are system specific  Meeting multiple customer requirements

13. Moving Forward “A project well planned is a project already half done well.”

14. Tackling the Challenges Be proactive Develop strategy and a LRP Identify ROI and Business Value, in advance Define a core solution Conduct a Gap Analysis

15. 5 Point Solution A core system that is;  Flexible and scaleable  Standards based  Integration compatible with multiple enterprise  Validation compatibility  Leverages existing infrastructure

16. Why a 5 Point Solution? Business Value;  First mover advantage- let clients connect to you  Scale with company and client growth  Standardization adjusts to new customer and regulatory mandates  Not if, but when Reduce integration costs

17. Next Steps… • Conduct a Gap Analysis • Map all relevant processes • Identify all work areas effected • Discover efficiencies from automation • Gather business requirements • From customers (their needs and requirements) • Internally • Conduct an independent vendor assessment

18. How can PharmTech help? Michael Stewart mstewart@pharmtechinc.com (847) 281-8924 Office (815) 403-8425 Cell

Cpo cmo serialization back to school

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (10)

Similar to Cpo cmo serialization back to school

Similar to Cpo cmo serialization back to school (20)

Recently uploaded

Recently uploaded (20)

Cpo cmo serialization back to school