SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
Taking place on the 20th and 21st January 2016, London UK, Pharmaceutical Microbiology event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology.
Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Gain an in-depth insight into endotoxin testing, validation and LER. Understand the threats posed by VBNCs and how to detect them.
For more information or to register for this conference please visit:
www.pharma-microbiology.com/lin
Book by 30th October and save £200!
Book by 30th November and save £100!
Webinar: Closed Sampling, a Critical Component for Every Risk Mitigation Stra...MilliporeSigma
Participate in the interactive webinar now: http://bit.ly/ClosedSamplingWebinar
Sampling should never put your process or sample at risk of contamination resulting in loss of time, money or regulatory scrutiny. This webinar discusses simple and effective sampling options to implement a secure sampling operation across your entire process driving towards closed manufacturing.
Explore our webinar library: www.emdmillipore.com/webinars
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Mitigating Supply Chain Risk using Big Data AnalyticsMilliporeSigma
Access the interactive recording: https://bit.ly/2M2fvWS
Abstract:
Growth and expansion in the biopharmaceutical industry have increased the vulnerability of the global supply chain to disruptions. At the same time, stronger regulatory oversight has been introduced to assure patient access to life-saving drugs. To stay ahead of these two factors, we are making “risk-smart” decisions to balance investments in capacity and supply programs.
The routine, reliable supply of products to biopharmaceutical manufacturers depends upon a disciplined approach to supply chain management and risk management. This webinar will talk about supply chain risk management, and more specifically how big data analytics can help strengthen supply chains.
In this webinar, you will learn more on:
- Our supply risk management program
- How we use big data analytics to determine risks
SMi’s 4th annual Peptides conference will give you the perfect platform to network, collaborate and learn over 2 days, featuring various key presentations by senior level industry professionals. With topics such as peptide formulation and delivery, as well as new advances in alternative peptide analysis technologies, Cell Penetrating Peptides, enhancements in synthesis mechanisms, analytical monitoring techniques, and many more.
AUTOMATED INFORMATION RETRIEVAL MODEL USING FP GROWTH BASED FUZZY PARTICLE SW...ijcseit
To mine out relevant facts at the time of need from web has been a tenuous task. Research on diverse fields
are fine tuning methodologies toward these goals that extracts the best of information relevant to the users
search query. In the proposed methodology discussed in this paper find ways to ease the search complexity
tackling the severe issues hindering the performance of traditional approaches in use. The proposed
methodology find effective means to find all possible semantic relatable frequent sets with FP Growth
algorithm. The outcome of which is the further source of fuel for Bio inspired Fuzzy PSO to find the optimal
attractive points for the web documents to get clustered meeting the requirement of the search query
without losing the relevance. On the whole the proposed system optimizes the objective function of
minimizing the intra cluster differences and maximizes the inter cluster distances along with retention of all
possible relationships with the search context intact. The major contribution being the system finds all
possible combinations matching the user search transaction and thereby making the system more
meaningful. These relatable sets form the set of particles for Fuzzy Clustering as well as PSO and thus
being unbiased and maintains a innate behaviour for any number of new additions to follow the herd
behaviour’s evaluations reveals the proposed methodology fares well as an optimized and effective
enhancements over the conventional approaches.
Taking place on the 20th and 21st January 2016, London UK, Pharmaceutical Microbiology event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology.
Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Gain an in-depth insight into endotoxin testing, validation and LER. Understand the threats posed by VBNCs and how to detect them.
For more information or to register for this conference please visit:
www.pharma-microbiology.com/lin
Book by 30th October and save £200!
Book by 30th November and save £100!
Webinar: Closed Sampling, a Critical Component for Every Risk Mitigation Stra...MilliporeSigma
Participate in the interactive webinar now: http://bit.ly/ClosedSamplingWebinar
Sampling should never put your process or sample at risk of contamination resulting in loss of time, money or regulatory scrutiny. This webinar discusses simple and effective sampling options to implement a secure sampling operation across your entire process driving towards closed manufacturing.
Explore our webinar library: www.emdmillipore.com/webinars
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Mitigating Supply Chain Risk using Big Data AnalyticsMilliporeSigma
Access the interactive recording: https://bit.ly/2M2fvWS
Abstract:
Growth and expansion in the biopharmaceutical industry have increased the vulnerability of the global supply chain to disruptions. At the same time, stronger regulatory oversight has been introduced to assure patient access to life-saving drugs. To stay ahead of these two factors, we are making “risk-smart” decisions to balance investments in capacity and supply programs.
The routine, reliable supply of products to biopharmaceutical manufacturers depends upon a disciplined approach to supply chain management and risk management. This webinar will talk about supply chain risk management, and more specifically how big data analytics can help strengthen supply chains.
In this webinar, you will learn more on:
- Our supply risk management program
- How we use big data analytics to determine risks
SMi’s 4th annual Peptides conference will give you the perfect platform to network, collaborate and learn over 2 days, featuring various key presentations by senior level industry professionals. With topics such as peptide formulation and delivery, as well as new advances in alternative peptide analysis technologies, Cell Penetrating Peptides, enhancements in synthesis mechanisms, analytical monitoring techniques, and many more.
AUTOMATED INFORMATION RETRIEVAL MODEL USING FP GROWTH BASED FUZZY PARTICLE SW...ijcseit
To mine out relevant facts at the time of need from web has been a tenuous task. Research on diverse fields
are fine tuning methodologies toward these goals that extracts the best of information relevant to the users
search query. In the proposed methodology discussed in this paper find ways to ease the search complexity
tackling the severe issues hindering the performance of traditional approaches in use. The proposed
methodology find effective means to find all possible semantic relatable frequent sets with FP Growth
algorithm. The outcome of which is the further source of fuel for Bio inspired Fuzzy PSO to find the optimal
attractive points for the web documents to get clustered meeting the requirement of the search query
without losing the relevance. On the whole the proposed system optimizes the objective function of
minimizing the intra cluster differences and maximizes the inter cluster distances along with retention of all
possible relationships with the search context intact. The major contribution being the system finds all
possible combinations matching the user search transaction and thereby making the system more
meaningful. These relatable sets form the set of particles for Fuzzy Clustering as well as PSO and thus
being unbiased and maintains a innate behaviour for any number of new additions to follow the herd
behaviour’s evaluations reveals the proposed methodology fares well as an optimized and effective
enhancements over the conventional approaches.
GICSA es la empresa líder en el desarrollo, inversión, comercialización y operación de centros comerciales, oficinas corporativas y naves industriales.
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
Gathering a room of Senior Scientists and Heads of Pharmaceutical Engineering, the 5th annual show provides an ideal forum to discuss the latest advancements in pharmaceutical lyophilisation, welcoming regulatory guidance from the NIBSC-MHRA and expertise from the likes of Sanofi, Boehringer Ingelheim, Roche, Novo Nordisk and more!
Aseptic Process Sampling to address Risk of Contamination & Containment in co...Merck Life Sciences
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
The Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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
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
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
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.
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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
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
1. KEY BENEFITS FOR 2017:
• Discuss the challenges involved with microbial control with
Takeda
• Following the path to efficient sterility assurance with GSK
• Bimeda highlight the importance of environmental modelling
• Delve into the latest developments in rapid microbial
methods with Janssen
• Hear the latest on data integrity and compliance with Roche
SMi present the 7th in its series...
Hyatt Regency Mission Bay, San Diego, USA
Pharmaceutical
Microbiology USA
Addressing the current challenges in sterility assurance, environmental monitoring
and RMM whilst evaluating the latest trends and opportunities for microbial control.
WORKSHOPS: 7TH
CONFERENCE:
8TH - 9TH
JUNE
2017
REGISTER BY 28TH FEBRUARY AND SAVE $300
REGISTER BY 31ST MARCH AND SAVE $200
REGISTER BY 28TH APRIL AND SAVE $100
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184,
Fax +44 (0) 20 7827 6185, email fbegum@smi-online.co.uk
or visit www.smi-online.co.uk/ts05.asp to register online @SMIPHARM
#smimicrobiology
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS
Wednesday 7th June 2017, Hyatt Regency Mission Bay, San Diego, USA
Technologies for Monitoring Contamination Control
and Case Studies on Contamination Control
08.30 – 12.30
Workshop Leaders:
Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation
Andrew Bartko, Research Leader, Battelle Memorial Institute
Microbial Required Use for
Terminal Sterilization
13.30 – 17.30
Workshop Leader:
Jerry Dalfours, Principal, JD Technologies
Sponsored by
CHAIRS FOR 2017:
• Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK
• John Duguid, Senior Director, Research & Development,
Vericel Corporation
EXPERT SPEAKER PANEL INCLUDE:
• Ron Smith, Director, External Supply Integration Quality, Janssen
• Ren-Yo Forng, Scientific Director, Amgen
• Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda
• Lina Orjuela, Microbiologist, Merck
• Paul Ricciatti, Sterility Assurance Manager, Bimeda
• Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
• Akua Gilbert-Arthur, Principal Scientist,
Roche Molecular Systems
2. Pharmaceutical Microbiology USA
Day One | Thursday 8th June 2017 Online at www.smi-online.co.uk/ts05.asp
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK
OPENING ADDRESS
09.10 Retracing the path to sterility assurance: An USP journey
• Update on latest revisions of USP microbiology chapters
• Discussion of work activities for revising chapter on sterility
assurance
• Current thinking about sterile product evaluation topics
(bacterial endotoxins testing, alternative pyrogen test,
container closure integrity evaluation, sterility test)
Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK
ENVIRONMENTAL MONITORING
09.50 The importance of environmental monitoring
• Environmental monitoring in today’s pharmaceutical
industry is imperative to avoid potential risks to consumers
and to save time and cost to manufacturers
• Rules governing dispersion of airborne microbial
contaminants and how contaminants can accumulate
in invisible vortices and airborne contamination
• How to evaluate representative sampling locations for
environmental monitoring during aseptic processes
Paul Ricciatti, Sterility Assurance Manager, Bimeda
10.30 Morning Coffee
11.00 Environmental monitoring trend analysis tools
• The importance of proper analysis and evaluation of
viable EM results.
• Development of a “tool box” in order to produce
specialized data reports.
• A case study in using the correct tools to demonstrate
environmental control in a cleanroom environment
Steve Walton, Technical Manager, Sterility Assurance,
Sanofi
11.40 Gram negative LPS structural alterations in response to
environmental stimuli
• Overview of how gram negative bacteria adapt to
various environmental conditions
• The role of modulation of outer membrane components
has on facilitating environmental adaptation
• The effect of external stimuli and structural adaptation
has on the classical LPS architecture
John Dubczak, Director of Operations,
Charles River
12.20 Networking Lunch
CHALLENGES IN ENDOTOXIN RECOVERY & STERILITY ASSURANCE
13.20 Challenges in endotoxin testing
• Advantages of in-process control
• Issues occurring in the detection of endotoxins
• Utilising the alternative endotoxin reagents and/or
methods to detect potential contaminants in products
Ren-Yo Forng, Scientific Director, Amgen
14.00 Interactive extended training session:
Effects of cleanrooms and barrier systems
on environmental monitoring data
Recent warning letters show that manufacturers of aseptic
products are receiving the most 483s; many are related
to smoke studies. Smoke / Airflow Visualization tests are
often performed by third party certifiers. However, per
FDA guidance, dynamic in-situ air pattern analysis is
more complex. These studies should be investigative and
effective at identifying design flaws or airflow issues. They
should be performed using the correct type of smoke,
smoke density, and camera angles.
• A closer look at existing regulation
(e.g. Pharm. Eur., USP, PDA)
• Why do we need to implement rapid microbial
methods vs classical microbial methods?
• How to evaluate the best RMM for each application
• Validation strategy, regulatory strategy and examples
of return of experiences
Morgan Polen, Subject Matter Expert on Contamination
Control, Microrite
15.00 Afternoon Tea
15.30 Bringing the cleanroom online after an adverse event
• Environmental control of classified areas within a
biopharmaceutical facility - maintained by systems
controlling humidity, air temperature, air exchanges,
filtration and pressure differentials
• When any of these systems or practices fail, it’s
considered a “Worst Case Event” which has the potential
to impact the clean state of a Classified Area
• FDA Warning Letters and 483s will be covered that focus
on cleanroom shut down and start up procedures
Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
16.10 Microbiological examination of non-sterile products
• Experience with USP <61> and USP <62> tests
• Utilising these test to provide harmonization with the
European Pharmacopeia methods
• Challenges incurred and lessons learnt
Elizabeth Hulanick, Microbiologist, Renaissance
Pharmaceuticals
16.50 Chairman’s Closing Remarks and Close of Day One
Sponsored by
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join
the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Charles River
Protecting the integrity of your products requires a reliable partner at all critical junctures in the QC process. We’ve purposely built our
portfolio to bring you progressive products and services that deliver accurate, relevant and reliable data to fuel confident decisions
on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial
detection and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and
smoothly,lowersyourcosttomanufactureandprotectsyourreputation. www.criver.com/products-services/manufacturing-support
Rapid Micro Biosystems delivers the Growth Direct™ System, an automated, non-destructive rapid detection and enumeration
technology based on the compendial method for microbial quality control in pharmaceutical manufacturing. The system
automates and accelerates detection and enumeration in the areas of environmental monitoring, bioburden and sterility testing
eliminating manual steps and analysis. The Company’s Growth DirectTM System detects contamination earlier, delivering compelling
economic benefits to manufacturers, while improving their quality process. The Growth Direct System is the first and only automated
system that addresses all key microbial QC applications and fits with current regulatory practices, a critical accelerator for adoption.
Automated analysis eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers
to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses, delivering significant cost savings
and increased operational efficiency. www.rapidmicrobio.com
3. Pharmaceutical Microbiology USA
Online at www.smi-online.co.uk/ts05.asp Day Two | Friday 9th June 2017
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
John Duguid, Senior Director, Research & Development,
Vericel Corporation
RAPID MICROBIAL METHODS
OPENING ADDRESS
09.10 Challenges involved with microbial control
• A CMO-focused microbial control strategy
• The challenges with managing an external
manufacturing program
• Looking to the future
Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda
09.50 Validation of a Rapid Microbial Method: Case studies for
microbial limits and sterility testing.
• Overview of the approach for testing equivalence of a
qualitative method
• Demonstrating equivalence to pour plate method for
Microbial Limits testing of betamethosone suspension
• Demonstrating equivalence to membrane filtration
sterility test method for a saline product
Ronald Smith, Director, External Supply Integration Quality,
Janssen
10.30 Morning Coffee
11.00 US approval of three rapid microbiological methods for
MACI product release
• Same day product release is needed for MACI®
(autologous cultured chondrocytes on porcine collagen
membrane)
• Automated rapid microbiological methods enable test
results within hours
• Regulatory requirements are continuing to evolve
John Duguid, Senior Director, Research & Development
Vericel Corporation
DATA INTEGRITY
11.40 Data integrity and compliance
• Current limitations with data integrity
• How to improve the reliability of data is necessary
to support clinical trials, product development and
manufacturing, and testing and reporting requirements
• Examining data integrity in relation to related to
pharmaceutical microbiology, including environmental
monitoring and laboratory analysis
Akua Gilbert-Arthur, Principal Scientist,
Roche Molecular Systems
12.20 Networking Lunch
13.20 Lessons learned in microbial data integrity management
• Data integrity within analytical and microbiology
laboratories for all phases of the drug product lifecycle
• What works well? How can it be improved?
• Examining the recently released draft guidance data
integrity and compliance with CGMP guidance for industry
Lina Orjuela, Microbiologist, Merck
BIOFILMS & OTHER CONTAMINANTS
14.00 Additional background on biofilm, its impacts in
healthcare, her discovery, and current testing.
• We are losing the war on bacteria. One of the reasons is
biofilm -- the sticky substance that bacteria form in order
to attach to surfaces and then shield the developing
colony from environmental stresses
• It is no coincidence that every bacterium on the lists
of the Center for Disease Control are biofilm-formers:
urgent threats (C. diff, etc.), pandemic threats
(pneumonia, T.B., E.coli, Salmonella, Listeria, cholera,
plague, etc.), bioterror threats (anthrax, etc.),, and
antimicrobial-resistant strains (MRSA, MDR-TB, CRES, etc.)
• As biofilm builds it captures other bacteria, and there is
evidence of horizontal gene transfer between different
species
• There are few remedies for biofilm. Scraping and
sterilization work, but they are short term. Biofilm was
recorded on a titanium plate within 30 seconds after
sterilization
• The human immune system, biocides and antibiotics are
designed to kill free-floating bacteria. Nothing known
can remove pre-formed biofilm at non-lethal doses
Cynthia Burzell, Founder & CSO, Aequor, Inc.
14.40 Afternoon Tea
15.10 Challenges with contamination issues
• Mold - A simple method to eliminate and prevent mold
anywhere.
• Biofilm - Simple and fast methods to eliminate and
prevent biofilm
• Spores - Simple ways to eliminate quickly and safe for
your equipment/surfaces
Brian Hubka, CEO, BGH International, LLC
15.50 Common errors in microbial identification and implications
• Phenotypic vs. Genotypic systems-capabilities and
deficiencies
• Deficient media quality control
• Microbiology laboratory training deficiencies that lead
to errors
• Growth media and incubation errors
• Gram staining errors
• What to do when in doubt
• Case studies
Ziva Abraham, CEO, Microrite
16.30 Chairman’s Closing Remarks and Close of Day Two
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Zoe Gale, SMi Marketing on +44 (0) 207 827 6132 or email: zgale@smi-online.co.uk
Supported byOfficial Media Partners:
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online
4. Overview of the workshop:
This session will discuss pathways to use the data obtained from
environmental monitoring to provide proactive and practical
solutions for comprehending and managing everyday
pharmaceutical microbiology challenges. This presentation will
cover case studies on human flora and spore contamination
in cleanroom operations. The workshop will cover the most
common causes of contamination: operators, items brought
into the cleanroom, and degradation of the cleanroom over
time. Case studies in operator borne contamination will be
discussed as well as preventative long term solutions. Targeted
long term solutions will be discussed regarding the spore case
studies in a concerted effort to limit reoccurrences. The overall
objective and scope of this seminar will be to discuss specifi c
cases studies that have occurred in my years of experience
in the industry. The concepts of cleaning and disinfection,
application frequency, disinfectant rotation, and rinsing and
residue removal strategies will be covered as well.
Why should you attend this workshop:
This industry workshop will give attendees valuable insight into
the world of contamination control and troubleshooting fungal
and bacterial spore excursions in cleanrooms. Attendees will
gain new insight into common causes of CAPA investigations
which will cut down on time that is invested finding potential
causes for contamination which can cost an organization 50K
per investigation.
Programme
08.30 Registration & Coffee
09.00 Opening remarks & introductions
09.15 Introduction
• Conventional methods
• Limitations
09.45 Sensing fundamentals
• Absorption and fluorescence
• Vibrational and Raman spectroscopy
• Mass spectrometry
10.30 Morning Coffee
11.00 Utilisation of spectrometric methods
• Advantages and limitations of new methods
• Comparisons to traditional microbial quality control
11.30 Industry case studies
• Vegetative organisms
• Fungal spores
• Bacterial spores
12.15 Interactive exercise
12.30 End of workshop
About the Workshop Leaders:
Mr. Polarine is a senior technical service manager
at STERIS Corporation. He has been with STERIS
Corporation for sixteen years. His current technical
focus is microbial control in cleanrooms and other
critical environments. He is active as co-chair on the PDA’s
microbial investigations task force. He was a co-author on
PDA’s Technical Report #70 on Cleaning and Disinfection. He
is a member of the PDA’s Environmental Monitoring Group,
Contamination Control Group, and Biotech Interest Group.
Dr. Andrew P. Bartko received a B.S. from the
University of Pittsburgh in 1997 and a Ph.D. in physical
chemistry in 2002. Dr. Bartko is a senior scientist in
Battelle’s Technology Development Group where
he contributes to several applied spectroscopy efforts that
focus on biological and chemical sensing. Dr. Bartko is the
manager and technical leader of an interdisciplinary team
that is developing Battelle’s Resource Effective Bioidentifi
cation System (REBS).
About the Organisation:
STERIS is a global leader in infection
prevention, contamination control,
surgical and critical care technologies,
and more. STERIS is the world’s pre-eminent infection
prevention, decontamination, and surgical and critical care
company. Every day, the people of Battelle apply science
and technology to solving what matters most. At major
technology centers and national laboratories around the
world, Battelle conducts research and development, designs
and manufactures products, and delivers critical services for
government and commercial customers.
Technologies for Monitoring
Contamination Control and Case Studies
on Contamination Control
Workshop Leaders: Jim Polarine Jr, Senior Technical
Service Manager, STERIS Corporation and Andrew Bartko,
Research Leader, Battelle Memorial Institute
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 7th June 2017
08.30 – 12.30
Hyatt Regency, Mission Bay, San Diego, CA
5. Overview of the workshop:
Determining best way to work with Microorganisms to ensure
we have sterilization that verifies we have no patient risk or
product stability issues due to survival of the microorganism
or damage to the product due to sterilization.
Why should you attend this workshop:
Knowing how to most effectively establish your D-values,
Z-values, F-values and Fbio-values along with Fo, FH and
lethality based on your bioburdens and any biological
indicator you select to use in your process based on the
variables associated with so many different issues associated
with different products that all need to be proven to be
sterile prior to distribution.
Programme
13.30 Registration & Coffee
14.00 PNSU – BIOBURDEN – Probability Function D values,
Z values and Fo
• How were those established?
• Where Did “Fo” start relative the microbial
impact
• Microbiological D value variations
• Can’t typically use what the vendor provides for
D values and Z values based on your product
trying to be sterilized.
• Typical BI Death Curve and Fraction Negative
• D121 value, Z value and Determination of Fo
• Bioburden Monitoring and determination of
potential sterilization risk compared to any
biological indicator
15.30 Afternoon Tea
16.00 Recent FDA Sterilization Observations Resulting
in Warning Letters – Providing what the FDA has
written about a variety of different situations that
has caused significant concerns based on many
companies not having the correct perspective
about Microbiological Sterilization.
17.20 Closing remarks
17.30 End of workshop
About the Workshop Leader:
Mr. Jerry Dalfors has extensive (40+ years) of
business administration, consultative, technical
and managerial experience in the development
and manufacture of highly regulated
biopharmaceutical products including injectables,
biologics, medical devices and oral dosages. He has held
permanent employee, temporary employee and company
representative management positions with a multitude of
the major pharmaceutical and biotechnology companies in
the US. He has worked with or assisted more than two dozen
companies with the establishment of controlled document/
qualitysystems,FDAbriefingandsubmittaldocuments,project
management of several multimillion dollar projects including
design, start-up and validation to assure fast track FDA
approval by maintaining strict regulatory compliance during
all phases of engineering, construction, commissioning and
validation, and has written numerous submission documents
for product, process and facility approval/licensing which also
required the development of quality systems which included
customer complaint management, deviation management,
CAPA and associated site wide employee training. Each of
his projects have been received and accepted by the FDA
and other regulatory agencies. Jerry is considered and expert
in most all aspects of the biopharmaceutical and medical
device industry and has trained many FDA field inspectors on
a variety of topics. None of his work has ever received a 483
but has corrected and prevented many along with Warning
Letter remediation.
About the Organisation:
JD Technologies provides consulting, regulatory and
documentation support to the pharmaceutical and
biopharmaceutical industries. JD Technologies prides itself
on being able to succesfully carry a project from concept to
completion, and integrating with other company employees
and contractors in a team effort.
Microbial Required Use for
Terminal Sterilization
Workshop Leader:
Jerry Dalfours, Principal, JD Technologies
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 7th June 2017
13.30 – 17.30
Hyatt Regency, Mission Bay, San Diego, CA
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VENUE Hyatt Regency, Mission Bay, San Diego, CA, USA
PHARMACEUTICAL MICROBIOLOGY USA
Conference: Thursday 8th & Friday 9th June 2017, Hyatt Regency, Mission Bay, San Diego, CA, USA Workshop: Wednesday 7th June 2017, San Diego, CA, USA
4 WAYS TO REGISTER
Online at www.smi-online.co.uk/ts05.asp
FAX your booking form to +44 (0) 20 7827 6184
PHONE on +44 (0) 20 7827 6185
POST your booking form to: Fateja Begum, SMi Group Ltd,
Ground & First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK
□ Book by 28th February to receive $300 off the conference price
□ Book by 31st March to receive $200 off the conference price
□ Book by 28th April to receive $100 off the conference price
I would like to attend: (Please tick as appropriate) Fee
□ Conference & 2 Workshops $2897.00
□ Conference & 1 Workshop A □ B □ $2398.00
□ Conference only $1899.00
□ 2 Workshops $998.00
□ 1 Workshop only A □ B □ $499.00
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees $1598 + VAT $1917.60
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.