Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Ph.D.
The changing environment for pharmaceutical microbiology
Limitations of methods
Need for new (rapid) methods
Separating people form processes
Single-use technologies
Environmental monitoring programme
Best practices
Rapid methods
Contamination control strategy
Objectionable organisms
Burkholderia cepacia complex
Evaluation of various /certified fixed orthodontic courses by Indian dental a...Indian dental academy
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and offering a wide range of dental certified courses in different formats.
Indian dental academy provides dental crown & Bridge,rotary endodontics,fixed orthodontics,
Dental implants courses.for details pls visit www.indiandentalacademy.com ,or call
0091-9248678078
Considering: Environmental monitoring guidance, Background to USP <1116>, Main changes and debates Method limitations, Incident rates, Frequencies of monitoring, Locations of monitoring, Other changes, Regulatory issues and Rapid methods
Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Ph.D.
The changing environment for pharmaceutical microbiology
Limitations of methods
Need for new (rapid) methods
Separating people form processes
Single-use technologies
Environmental monitoring programme
Best practices
Rapid methods
Contamination control strategy
Objectionable organisms
Burkholderia cepacia complex
Evaluation of various /certified fixed orthodontic courses by Indian dental a...Indian dental academy
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and offering a wide range of dental certified courses in different formats.
Indian dental academy provides dental crown & Bridge,rotary endodontics,fixed orthodontics,
Dental implants courses.for details pls visit www.indiandentalacademy.com ,or call
0091-9248678078
Considering: Environmental monitoring guidance, Background to USP <1116>, Main changes and debates Method limitations, Incident rates, Frequencies of monitoring, Locations of monitoring, Other changes, Regulatory issues and Rapid methods
Understanding How Bioburden and Sterilization Affect Medical DevicesPacific BioLabs
This presentation covers:
Bioburden- what is it and how it can affect a device development program and sterilization validation program.
Sterilization: methods and the bioburden-sterilization connection.
Benefits of minimizing the sterilization dose for your device.
Importance of monitoring bioburden.
Case study: sterilization failure and tracking down root cause.
How to monitor and reduce bioburden levels.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Contoh Protokol Validasi Metode Analisis Mikrobiologi #3Guide_Consulting
Validation of Analytical Methods for the Detection of Microbial pathogens in Foods
Untuk mendapat file nya silahkan kirimkan email beserta data (nama, perusahaan, alamat email, no telp) ke Guide Consulting | info@traininglaboratorium.com
Merupakan penggalan USP 36 chapter 1116 mengenai Microbiological Control And Monitoring Of Aseptic Processing Environments
Untuk mendapat softcopy atau informasi lebih lanjut silahkan hubungi delli.intralab@gmail.com
Laboratory is a place that is equipped with different instruments, equipments and chemicals (reagents) etc., for performing experimental works, research activities and investigative procedures.
Medical laboratory is one part of the laboratory that is equipped with various biomedical instruments, equipments, materials and reagents (chemicals) for performing different laboratory investigative activities by using biological specimens (whole blood, serum, plasma, urine, stool, etc).
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Understanding How Bioburden and Sterilization Affect Medical DevicesPacific BioLabs
This presentation covers:
Bioburden- what is it and how it can affect a device development program and sterilization validation program.
Sterilization: methods and the bioburden-sterilization connection.
Benefits of minimizing the sterilization dose for your device.
Importance of monitoring bioburden.
Case study: sterilization failure and tracking down root cause.
How to monitor and reduce bioburden levels.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Contoh Protokol Validasi Metode Analisis Mikrobiologi #3Guide_Consulting
Validation of Analytical Methods for the Detection of Microbial pathogens in Foods
Untuk mendapat file nya silahkan kirimkan email beserta data (nama, perusahaan, alamat email, no telp) ke Guide Consulting | info@traininglaboratorium.com
Merupakan penggalan USP 36 chapter 1116 mengenai Microbiological Control And Monitoring Of Aseptic Processing Environments
Untuk mendapat softcopy atau informasi lebih lanjut silahkan hubungi delli.intralab@gmail.com
Laboratory is a place that is equipped with different instruments, equipments and chemicals (reagents) etc., for performing experimental works, research activities and investigative procedures.
Medical laboratory is one part of the laboratory that is equipped with various biomedical instruments, equipments, materials and reagents (chemicals) for performing different laboratory investigative activities by using biological specimens (whole blood, serum, plasma, urine, stool, etc).
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Invitro Potency Analysis of Vancomyc in Capsules by Microbiological Assayiosrjce
Vancomyc in, a glycopeptide antibiotic, has a narrow spectrum of activity, with action primarily
against gram-positive cocci and bacilli. The drug is bacteriostatic against most enterococci and exhibits
synergy when combined with an aminoglycoside. Vancomycin has been used widely in treating many susceptible
infections, but the emergence of vancomycin-resistant enterococci. Now a days, It is used for the Treatment
of life threatening Pseudomembranous colitis infection caused by Clostridium difficile . In this work it deals
with invitro potency analysis of vancomycin capsules by microbiological assay. In the pharmaceutical industry,
drug dissolution testing is routinely used to provide vitro drug release information for both quality
control purposes. It is helpful for drug formulation design and post-approval manufacturing changes, stated by
food and drug administration (FDA). It is followed by microbiological assay to check the potency of the drug by
cylinder plate method for vancomycin (125 & 250mg) capsules against ATCC6633 Bacillus subtilis. The
comparison are restricted to relationship between zone diameter measurements within plates, excluding the
variation between plates. Individual plate response are normalized on the basis of the relation zone size of the
standard, compared to mean zone size of a standard across the plates. In this study, the vanomycin capsules
(125 & 250 mg) in raw materials, validation samples, finished products and stability samples showed the
accepted product potency of 98-105%. The assay is designed in such a way that the mathematical model on
which the potency equation is based can be proved to be VALID. In pharmaceutical company, before
commercialization of the drug into markets, the potency of vancomycin, shelf life is predetermined and got
approval of regulatory bodies and then released to commercialization to markets.
Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
Excel in Healthcare: George Group Of Colleges' Medical Lab Technician Coursesakshiksquare
George Group Of Colleges offers a comprehensive Medical Lab Technician Course, equipping students with essential skills for a successful career in healthcare. With hands-on training and expert faculty, prepare for a rewarding journey in medical laboratory technology. Enroll now for a brighter future. https://www.georgecollege.org/bsc-in-medical-lab-technology
ATCC y otros reguladores internacionales de bioderivados. Introduction to mic...Dr. Manuel Concepción
En la siguiente podemos ver como se integran productos terminados industriales sobre procesos de diagnóstico y tratamientos estandarizados, en este caso estamos hablando de bioreactores industriales y procesos de criogenización y liofilización, que son el stage 1 de un proceso industrial de biotecnología. Por que existen estas compañías certificadoras para que sociedades AEMED como la nuestra tengan una guía sobre la cual basar sus avances, hay muchas organizaciones privadas, públicas, y gubernamentales que se dedican a esto, elegí ATCC por que da formación específica gratuita y son asequibles y pueden colaborar en el futuro si AEMED esta a la altura con un proyecto propio.
Eric Ittah has shared a food and science PPT. He is a leading biopharmaceuticals consultant holding strong knowledge of different food processing methods
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In the Adani-Hindenburg case, what is SEBI investigating.pptxAdani case
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An introduction to the cryptocurrency investment platform Binance Savings.Any kyc Account
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Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
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Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
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Kyiv PMDay 2024 Summer
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Youtube – https://www.youtube.com/startuplviv
FB – https://www.facebook.com/pmdayconference
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3. A pharmaceutical microbiology lab is involved in :
Sterility Testing
Detection, isolation and identification of microorganism
Examining different samples with the use of microorganisms
Scope of a pharmaceutical microbiology lab
4. Microbiology testing must always be performed by
professionals who are qualified in microbiology. Adequate
training is required for competent performance of tests
and operation of equipment.Porfessionals must be trained
in safe handling of the microorganisms.
Personnel
5. Microbiology laboratories must be designed to suit the
tests that are carried out in them. Sufficient space must
be there so that there is no mix up of activities or
samples. Access to this area must be restricted to
authorized personnel only.
Environment
6. A proper cleaning and disinfection program
should be there to ensure that all the testing
activities are performed in a proper manner.
Cleaning and Hygiene
A proper procedure
must be there to deal
with the spillages.
Hand washing and
sanitization facilities
must be there in place.
7. Each type of equipment or any other devices must be
there in the microbiology lab to ensure that
testing, verification and calibration can be performed in a
desired way. The devices must be maintained so that the
tests can be performed accurately.
Equipment
8. All the chemicals including the
reagents, media, diluents, and other suspending
liquids must be
Labeling of chemicals
labeled to indicate
their
identity, concentration,
storage
conditions, preparatio
n date and expiry date
9. Using good practices in pharmaceutical microbiology labs
will ensure that all the tests are performed by
experienced professionals in a very hygienic and
disinfected environment using proper devices to get
accurate results.
Summary