Cpo cmo serialization back to school

•

1 recomendación•786 vistas

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.

Salud y medicina

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

Más contenido relacionado

La actualidad más candente

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)

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.

Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance

Perficient, Inc.

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.

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

Greenlight Guru

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

How to Comply with IDMP Regulatory Requirements

Perficient, Inc.

Description & functions of drug regulatory affairs

Cepal & Co.

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.

Life Sciences Executive Overview

Ryan Sonnenberg

Program Regulatory Affairs by IBRI Noida

IBRI Noida

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

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

Torben Haagh

IDMP and RIM: friend or foe?

eCTDconsultancy

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.

Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017

April Bright

Using the new OTC guidance to help compile a successful application

TGA Australia

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.

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

Perficient, Inc.

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

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

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.

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

April Bright

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

April Bright

La actualidad más candente (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...

Destacado

Infographic: Guide to Pharma Serialization

Shikha Saxena

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.

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

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.

New EU Requirements for Qualification & Validation

GMP EDUCATION : Not for Profit Organization

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

Destacado (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 a Cpo cmo serialization back to school

Proven Movilitas Process #3 - Requirements & Processes

Stefan Hockenberger

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

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

Perficient, Inc.

Pharm tech core traceability presentation

Michael Stewart

Stabicon Outsourcing Presentation

Stabicon123

Qumas Collaboration to Innovation Quality QMS PIMS 2014

GBX Summits

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/

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

CBX Software

IntegrtdAppro-GlblSuppChnTrans-Final-v2a

Mark 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 Slides

Geoff Rothman

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.

Alineación de requerimientos y pruebas de software

Software Guru

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

Sabrion_Consulting_Overview CPG Retail Apparel.pdf

Brion Carroll (II)

iGrafx | Business Process Management Solution Provider | ProServ UAE

ProServ

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.

Services catalogue 2019

Matilde Beltrandi, PhD

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

Building a Complete View Across the Customer Experience on Oracle BICS

Shiv Bharti

Knowledge acquisition group capabilities 2014 q1 (concise)

AnnettaColeman

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.

Rapidflow apps agile pg&c solution

MBist

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

PMI Pearl City Chapter

EBook-ProcessvsProject-LLamasoft

Bob McFarland

EBook-ProcessvsProject-LLamasoft

Manda Schweitzer-Miller

Similar a 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

Último

☑️░ 9630942363 ░ CALL GIRLS ░ VIP ░ ESCORT ░ SERVICES ░ AGENCY ░ 9630942363 THE GENUINE ESCORT AGENCY VIP LUXURY CALL GIRLS HIGH CLASS MODELS CALL GIRLS GENUINE ESCORT BOOK BOOK APPOINTMENT - 9630942363 THE GENUINE ESCORT AGENCY BEST VIP CALL GIRLS & ESCORTS SERVICE 9630942363 VIP CALL GIRLS ALL TYPE WOMEN AVAILABLE INCALL & OUTCALL BOTH AVAILABLE BOOK NOW 9630942363 VIP GENUINE INDEPENDENT ESCORT AGENCY VIP PRIVATE AUNTIES BEAUTIFUL LOOKING HOT AND SEXT GIRLS AND PARTY TYPE GIRLS YOU WANT SERVICE THEN CALL THIS NUMBER 9630942363 ROOM ALSO PROVIDE HOME & HOTELS SERVICE FULL SAFE AND SECURE WORK WITHOUT CONDOMS, ORAL, SUCKING, LIP TO LIP, ANAL, BACK SHOTS, SEX 69, WITHOUT BLOWJOB AND MUCH MORE FOR BOOKING 9630942363

Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...

Genuine Call Girls

Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available Easy & Fast Booking Procedure Of Gwalior Escorts Call girls are ready and waiting to provide the quality essentialness that will help ease away life's tensions Gwalior Escorts are regular companions of elite gentlemen and can take them places they could only dream of visiting. These ladies take great care in maintaining themselves to look appealing; visiting salons and spas regularly keeps them looking their best; their portfolios can be found online via an escort’s agency website. EXCITING OPTIONS AVAILABLE AT OUR INDEPENDENT ESCORTS Candlelight dinner Evening date Night clubs or parties Hotels or your flats Business trip Business party Stripping party Gwalior Escort Service are adept at performing wild anal sex, deep throat sex and cum eating - perfect for satisfying all your sexual needs and playing any game imaginable. Affordable professional assistants are readily available and ready to assist with any situation - be it romantic date or solo night. Their beautiful appearances and striking personalities will leave you speechless, while they can accompany you to restaurants or bars where their presence will surely leave an impression.

Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available

Dipal Arora

Call Girls Bangalore Just Call 8250077686 Top Class Call Girl Service Available Call Girls Bangalore Just Call 8250077686 Top Class Call Girl Service Available Easy & Fast Booking Procedure Of Bangalore Escorts Call girls are ready and waiting to provide the quality essentialness that will help ease away life's tensions Bangalore Escorts are regular companions of elite gentlemen and can take them places they could only dream of visiting. These ladies take great care in maintaining themselves to look appealing; visiting salons and spas regularly keeps them looking their best; their portfolios can be found online via an escort’s agency website. EXCITING OPTIONS AVAILABLE AT OUR INDEPENDENT ESCORTS Candlelight dinner Evening date Night clubs or parties Hotels or your flats Business trip Business party Stripping party Bangalore Escort Service are adept at performing wild anal sex, deep throat sex and cum eating - perfect for satisfying all your sexual needs and playing any game imaginable. Affordable professional assistants are readily available and ready to assist with any situation - be it romantic date or solo night. Their beautiful appearances and striking personalities will leave you speechless, while they can accompany you to restaurants or bars where their presence will surely leave an impression.

Call Girls Bangalore Just Call 8250077686 Top Class Call Girl Service Available

Dipal Arora

VIP Call Girls Indore Kirti 💚😋 9256729539 🚀 Indore Escorts 🔝 9256729539🔝✔️✔️ One shot: ₹2000/in-call, ₹5000/out-call Two shots with one girl: ₹3500 /in-call, ₱6000/out-call Body to body massage with sex: ₱3000/in-call Full night for one person: ₱7000/in-call, ₱10000/out-call Full night for more than 1 person : Contact us at 9256729539. for details Operating 24/7, we serve various locations in Indore. For premium call girl services in Indore 9256729539. Thank you for considering us !

VIP Call Girls Indore Kirti 💚😋 9256729539 🚀 Indore Escorts

aditipandeya

The Most Attractive Hyderabad Call Girls Kothapet 𖠋 6297143586 𖠋 Will You Miss This Chance Of Getting Into My Sexy Boobs? Booking Contact Details WhatsApp Chat: +91-6297143586 Hyderabad Escort Service includes providing maximum physical satisfaction to their clients as well as engaging conversation that keeps your time enjoyable and entertaining. Plus they look fabulously elegant; making an impressionable Independent Escorts Hyderabad understands the value of confidentiality and discretion - they will go the extra mile to meet your needs. Simply contact them via text messaging or through their online profiles; they'd be more than delighted to accommodate any request or arrange a romantic date or fun-filled night together. We provide - Flexibility Choices and options Lists of many beauty fantasies Turn your dream into reality Perfect companionship Cheap and convenient In-call and Out-call services And many more. 01-May(Ast)

The Most Attractive Hyderabad Call Girls Kothapet 𖠋 6297143586 𖠋 Will You Mis...

chandars293

(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Celebrity for 5* Hotels Booking Details Are here 05-May-2024( Mj) Click On WhatsApp Chat +91-8445551418 Jaipur Escorts Make You Feel Like Royalty Jaipur Escorts catering to high profile clients are available 24-7 to meet their clients' needs and are also available for dinner dates, business conferences, foreign travel trips and clubbing activities. Their customers are contacted directly through in order to prevent risky situations from developing.is home to some of India's most beautiful women. These girls come highly educated with great backgrounds; furthermore they are extremely beautiful and will make you feel like royalty if hired for hours or days! Siya Khan | FOR BOOKING CALL Our All Services :- 1 )★ (Oral to consummation) bjnonCovered 2 )★ Special Massage 3 )★ O-Level (Oral sex) 4 )★ Blow Job; 5 )★ COB (Come On Body) 6 )★. Extraball (Have sex ordinarily) 7 )★ A-Level (5 star escort) 8 )★ Strip-bother 9 )★ BBBJ (Bareback Blowjob) 10 )★ Spending time in my rooms 11 )★ BJ (Blowjob Without a Condom) 12 )★ COF (Come On Face) 13 )★ Completion

(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...

parulsinha

Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent High Profile Call Girl 24×7 Booking Contact Details WhatsApp Chat: +91-9930245274 Mumbai Escort Service includes providing maximum physical satisfaction to their clients as well as engaging conversation that keeps your time enjoyable and entertaining. Plus they look fabulously elegant; making an impressionable. Independent Escorts Mumbai understands the value of confidentiality and discretion - they will go the extra mile to meet your needs. Simply contact them via text messaging or through their online profiles; they'd be more than delighted to accommodate any request or arrange a romantic date or fun-filled night together. We provide - Flexibility Choices and options Lists of many beauty fantasies Turn your dream into reality Perfect companionship Cheap and convenient In-call and Out-call services And many more. 29-04-24 (Smt)

Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...

Call Girls in Nagpur High Profile

EXPLORE THE BEST ESCORT SERVICE IN HARIDWAR These days people are very engaged with their hectic life timetable. Some are busy with the stress and hectic schedule in the office, while others have a partner but don't feel the same excitement as before. But don't worry; our sexy escort service in Haridwar is here to bring excitement back to your life. Luxury Escort Service is the best place to get some busty, sizzling, hot escorts who can help you relish all the moments and make the night unforgettable. We are one of the faithful escort agencies in Haridwar that provide escort services in Haridwar to the customers in the best practices. We apprehend that you need somebody who can listen to you and share some quality time with you, not being judgemental. Your privacy and hesitation are understandable while booking the Escort, but you can trust us as we have many clients who reach out to us repeatedly. You are at the right place if you are searching for a trustworthy and cheap escort service in Haridwar. Luxury Escort Service in Haridwar is the best place to get some seductive and hot escort girls service who can help you enjoy all the moments and make the night even more special. Vast numbers of independent escorts are working across Haridwar all day and night to make their clients happy as never before. If you feel so alone or get disheartened from the hectic life schedules, then nothing is better than having a mate who can give you a token of new love. Don't Worry, Guys; we are here for you. We are a highly demanded Luxury Escort Service in Haridwar that provides all types of escort services. We have top Haridwar models in Haridwar, highly sexy housewives in Haridwar, hot college girls in Haridwar, and beautiful independent escort girls in Haridwar to serve you with a sensual time that is matchless to all your unique experiences in life. Many escort agencies in Haridwar provide escort services in the market, but we have been operating in the industry for eight years to till date. We served Our Independent Escort Service to approximately 10000+ satisfied clients in Haridwar. Unlike other escort service companies in Haridwar, we give the client to mention their requirements and desires to cater to them with the best escort service in Haridwar.

College Call Girls in Haridwar 9667172968 Short 4000 Night 10000 Best call gi...

perfect solution

♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl 100% Genuine Please Contact Me Booking Contact Details WhatsApp Chat: +91-7001035870 Hyderabad Escort Service includes providing maximum physical satisfaction to their clients as well as engaging conversation that keeps your time enjoyable and entertaining. Plus they look fabulously elegant; making an impressionable Independent Escorts Hyderabad understands the value of confidentiality and discretion - they will go the extra mile to meet your needs. Simply contact them via text messaging or through their online profiles; they'd be more than delighted to accommodate any request or arrange a romantic date or fun-filled night together. We provide - Flexibility Choices and options Lists of many beauty fantasies Turn your dream into reality Perfect companionship Cheap and convenient In-call and Out-call services And many more. 29-Apr(Ast)

♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...

astropune

VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Their Home & Hotels Why you Choose Us- +91-7877925207 Hyderabad Escort Service includes providing maximum physical satisfaction to their clients as well as engaging conversation that keeps your time enjoyable and entertaining. Plus they look fabulously elegant; making an impressionable I Have Extremely Beautiful Broad Minded Cute Sexy & Hot Call Girls and Escorts, We Are Located in 3* 4* 5* Hotels. Safe & Secure High Class Services Affordable Rate 100% Satisfaction, Unlimited Enjoyment. Any Time for Model/Teens Escort in Delhi High class luxury and premium escorts agency. ★ CALL US High Class Luxury and Premium Escort Service We Provide Well Educated,Royal Class Female,High-Class Escort Service Offering a Top High Class Escort Service In The & Several Nearby All Places of . A300424ST ★ To Enjoy With Hot and Sexy Girls . ★ We Are Providing :- • 3* 5* 7*Hotels Service • Hygienic Full AC Neat and Clean Rooms Avail. • Daily New Escorts Staff Available • Minimum to Maximum Range Available. HOT⇄ 7877925207 Mr Chirag ji Our escort service •BJ (Blowjob) •FK (French kissing) •Kissing with tongue •O-Level (Oral sex) •Long Silky Brown Hair •69 (69 sex) •A-Level (5 start Escort) •Dating

VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...

jageshsingh5554

Call Girls Ludhiana Just Call 9907093804 Top Class Call Girl Service Available Call Girls Ludhiana Just Call 9907093804 Top Class Call Girl Service Available Easy & Fast Booking Procedure Of Ludhiana Escorts Call girls are ready and waiting to provide the quality essentialness that will help ease away life's tensions Ludhiana Escorts are regular companions of elite gentlemen and can take them places they could only dream of visiting. These ladies take great care in maintaining themselves to look appealing; visiting salons and spas regularly keeps them looking their best; their portfolios can be found online via an escort’s agency website. EXCITING OPTIONS AVAILABLE AT OUR INDEPENDENT ESCORTS Candlelight dinner Evening date Night clubs or parties Hotels or your flats Business trip Business party Stripping party Ludhiana Escort Service are adept at performing wild anal sex, deep throat sex and cum eating - perfect for satisfying all your sexual needs and playing any game imaginable. Affordable professional assistants are readily available and ready to assist with any situation - be it romantic date or solo night. Their beautiful appearances and striking personalities will leave you speechless, while they can accompany you to restaurants or bars where their presence will surely leave an impression.

Call Girls Ludhiana Just Call 9907093804 Top Class Call Girl Service Available

Dipal Arora

Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine Sex Service At Affordable Rate Booking Contact Details Whatsapp Chat :+91- 9332606886 These professional and Call girls in Bangalore can satisfy your every desire - be it sensual massage or an erotic shower, they are always more than willing to meet them. Furthermore, they pay close attention to body language cues to ensure you enjoy every minute spent in their company - both in-call and outcall services are offered. Is an excellent choice for anyone seeking an exciting and thrilling night of fun and excitement The Oberoi, Bengaluru Taj West End The Leela Palace Bengaluru JW Marriott Hotel Bengaluru The Ritz-Carlton, Bangalore Sheraton Grand Bangalore Hotel at Brigade Gateway Conrad Bengaluru ITC Gardenia, Bengaluru Renaissance Bengaluru Race Course Hotel The Lalit Ashok Bangalore 30 apr 24 (LK)

Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...

narwatsonia7

(Rocky) Jaipur Call Girl - 09521753030 Escorts Service 50% Off with Cash ON Delivery Booking Contact Details WhatsApp Chat : +91-9521753030 Get More Information About Jaipur Escorts Service Jaipur Escorts offer their services to their clients at any time of day or night - including sex, travel and tours. Contact them via telephone or the internet. Hire an escort as your movie partner, date or party companion - they're sure to exceed all your expectations. Girls available 24/7 make for great companions who offer sensual body massages and drinks/food service during your time together. Find one who fits with your personality or budget - these girls have you covered.

(Rocky) Jaipur Call Girl - 09521753030 Escorts Service 50% Off with Cash ON D...

indiancallgirl4rent

Are you looking for some sexual fun and erotic girl in the vibrant city of Lucknow? Look no further than our top-notch call girl services in Lucknow! Whether you prefer in-call or out-call services, we just need to call or WhatsApp us at 8800925952 In-call and Out-call services for Call girls in Lucknow Looking for privacy? Our in-call services provide a discreet and comfortable setting for your rendezvous with our lovely call girls in Lucknow. Best Price with hotel services When looking for the best-priced call girl in Lucknow, our services at Lucknow Call Girl Service stand out with our exceptional BDSM, GFE, Oral Experience, etc. We provide top-notch experiences that cater to your needs and desires, ensuring a memorable encounter every time. Call or WhatsApp us for more details - 8800925952

Lucknow Call girls - 8800925952 - 24x7 service with hotel room

discovermytutordmt

Call Girls Bareilly Just Call 8250077686 Top Class Call Girl Service Available Easy & Fast Booking Procedure Of Bareilly Escorts Call girls are ready and waiting to provide the quality essentialness that will help ease away life's tensions Bareilly Escorts are regular companions of elite gentlemen and can take them places they could only dream of visiting. These ladies take great care in maintaining themselves to look appealing; visiting salons and spas regularly keeps them looking their best; their portfolios can be found online via an escort’s agency website. EXCITING OPTIONS AVAILABLE AT OUR INDEPENDENT ESCORTS Candlelight dinner Evening date Night clubs or parties Hotels or your flats Business trip Business party Stripping party Bareilly Escort Service are adept at performing wild anal sex, deep throat sex and cum eating - perfect for satisfying all your sexual needs and playing any game imaginable. Affordable professional assistants are readily available and ready to assist with any situation - be it romantic date or solo night. Their beautiful appearances and striking personalities will leave you speechless, while they can accompany you to restaurants or bars where their presence will surely leave an impression.

Call Girls Bareilly Just Call 8250077686 Top Class Call Girl Service Available

Dipal Arora

Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available Easy & Fast Booking Procedure Of Nagpur Escorts Call girls are ready and waiting to provide the quality essentialness that will help ease away life's tensions Nagpur Escorts are regular companions of elite gentlemen and can take them places they could only dream of visiting. These ladies take great care in maintaining themselves to look appealing; visiting salons and spas regularly keeps them looking their best; their portfolios can be found online via an escort’s agency website. EXCITING OPTIONS AVAILABLE AT OUR INDEPENDENT ESCORTS Candlelight dinner Evening date Night clubs or parties Hotels or your flats Business trip Business party Stripping party Nagpur Escort Service are adept at performing wild anal sex, deep throat sex and cum eating - perfect for satisfying all your sexual needs and playing any game imaginable. Affordable professional assistants are readily available and ready to assist with any situation - be it romantic date or solo night. Their beautiful appearances and striking personalities will leave you speechless, while they can accompany you to restaurants or bars where their presence will surely leave an impression.

Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available

Dipal Arora

Night 7k to 12k Chennai City Center Call Girls 👉👉 7427069034⭐⭐ 100% Genuine Escort Service & Hotel Service Available Call Mr Chirag Ji +91-7427069034 We offer all types of girls of your choice with space. Our escorts are fully cooperative and understand your needs. All types of call girls like Housewives, College girls, Russian girls, Muslim girls, Afghani girls, Bengali girls, Working girls, south Indian girls, Punjabi girls, etc. In-Call: — You Can Reach At Our Place in Chennai Our place Which Is Very Clean Hygienic 100% safe Accommodation. Out-Call: — Service for Out Call You have To Come Pick The Girl From My Place We Also Provide Door-Step Services Hygienic: — Full Ac Neat And Clean Rooms Available In Hotel 24 * 7 Hrs In Chennai C010524HD Our Services and Rates: – One Shot — 2500/in call (time ½ hour), 5000/out call Two shot with one girl — 5000/in call (time 1 hour), 6000/out call Body to body massage with sex- 3000/in call (time 1 hour) full night for one person– 8000/in call, 10000/out call (shot limit 4 shot) We are available 24*7 all days of the year Call us — 7427069034 !! Thank you for Visiting.

Night 7k to 12k Chennai City Center Call Girls 👉👉 7427069034⭐⭐ 100% Genuine E...

hotbabesbook

Top Rated Bangalore Call Girls Richmond Circle ⟟ 9332606886 ⟟ Call Me For Genuine Sex Service At Affordable Rate Booking Contact Details Whatsapp Chat :+91- 9332606886 These professional and Call girls in Bangalore can satisfy your every desire - be it sensual massage or an erotic shower, they are always more than willing to meet them. Furthermore, they pay close attention to body language cues to ensure you enjoy every minute spent in their company - both in-call and outcall services are offered. Is an excellent choice for anyone seeking an exciting and thrilling night of fun and excitement The Oberoi, Bengaluru Taj West End The Leela Palace Bengaluru JW Marriott Hotel Bengaluru The Ritz-Carlton, Bangalore Sheraton Grand Bangalore Hotel at Brigade Gateway Conrad Bengaluru ITC Gardenia, Bengaluru Renaissance Bengaluru Race Course Hotel The Lalit Ashok Bangalore 30 apr 24 (LK)

Top Rated Bangalore Call Girls Richmond Circle ⟟ 9332606886 ⟟ Call Me For Ge...

narwatsonia7

Call Girls Ooty Just Call 8250077686 Top Class Call Girl Service Available Easy & Fast Booking Procedure Of Ooty Escorts Call girls are ready and waiting to provide the quality essentialness that will help ease away life's tensions Ooty Escorts are regular companions of elite gentlemen and can take them places they could only dream of visiting. These ladies take great care in maintaining themselves to look appealing; visiting salons and spas regularly keeps them looking their best; their portfolios can be found online via an escort’s agency website. EXCITING OPTIONS AVAILABLE AT OUR INDEPENDENT ESCORTS Candlelight dinner Evening date Night clubs or parties Hotels or your flats Business trip Business party Stripping party Ooty Escort Service are adept at performing wild anal sex, deep throat sex and cum eating - perfect for satisfying all your sexual needs and playing any game imaginable. Affordable professional assistants are readily available and ready to assist with any situation - be it romantic date or solo night. Their beautiful appearances and striking personalities will leave you speechless, while they can accompany you to restaurants or bars where their presence will surely leave an impression.

Call Girls Ooty Just Call 8250077686 Top Class Call Girl Service Available

Dipal Arora

Call Girls Siliguri Just Call 8250077686 Top Class Call Girl Service Available Easy & Fast Booking Procedure Of Siliguri Escorts Call girls are ready and waiting to provide the quality essentialness that will help ease away life's tensions Siliguri Escorts are regular companions of elite gentlemen and can take them places they could only dream of visiting. These ladies take great care in maintaining themselves to look appealing; visiting salons and spas regularly keeps them looking their best; their portfolios can be found online via an escort’s agency website. EXCITING OPTIONS AVAILABLE AT OUR INDEPENDENT ESCORTS Candlelight dinner Evening date Night clubs or parties Hotels or your flats Business trip Business party Stripping party Siliguri Escort Service are adept at performing wild anal sex, deep throat sex and cum eating - perfect for satisfying all your sexual needs and playing any game imaginable. Affordable professional assistants are readily available and ready to assist with any situation - be it romantic date or solo night. Their beautiful appearances and striking personalities will leave you speechless, while they can accompany you to restaurants or bars where their presence will surely leave an impression.

Call Girls Siliguri Just Call 8250077686 Top Class Call Girl Service Available

Dipal Arora

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

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Destacado

Destacado (10)

Similar a Cpo cmo serialization back to school

Similar a Cpo cmo serialization back to school (20)

Último

Último (20)

Cpo cmo serialization back to school