M Environmental Monitoring School th9 - 10 Novemberth 12 - 13 Octoberth th Sterility Testing School Sterility Testing & Environmental Monitoring School 2022
• Optimizing sterility testing procedures
This two day course provides an in-depth review of the regulatory requirements of sterility testing, its validation and practical implementation. The course is based on the most recent editions of pharmacopeias and provides information about the harmonization and differences between the United States Pharmacopeia (USP) and the European Pharmacopeia (EP).
` 15000/= per person for 2 days
• Develop and optimize sterility testing procedures
Hands-On Practical Section
Venue: Plot No. Bommasandr12,a-Jigani Link Road, Industrial Area, Anekal Taluku, Bengaluru-560100.
• Troubleshoot specific user-related situations
Which of your challenges does this course address?
Course Description
The course is designed primary for quality control, manufacturing or quality assurance personnel who perform or responsible for the performance of sterility test.
You will get a better understanding of the current requirements of pharmacopeias and be familiar with good sterility testing procedures from method development / validation through to routine test results
The practical section covers how to:
+91MATLabIndia@merckgroup.com9916697979
What will you receive?
• Use of Sterility Testing hardware
Sterility Testing School
• Certificate of Achievement
•interpretation:Takepreventive actions to avoid false positive or false negative test results
“Because Sterility Testing is a very exacting procedure, whereas asepsis of the procedure must be ensured for a correct interpretation of results. It is important that personnel be properly trained and qualified" - United States Phamacopeia General Chapters <71>.
Date: 12 - 13 October 2022
Who should attend?
• False positive test results
• Handling issues
• Demonstrate general specific sterility testing applications
In a hands-on interactive workshop, participants will learn how to perform sterility test. Participants’ case studies will also be discussed. The workshop will aid the understanding of the lecture contents with practical applications. All the critical handling steps in the sterility testing procedure and its consequences on test results are discussed and solutions are explained and demonstrated.
Code: BMSCHOOL1
Our experience trainers will also provide valuable suggestions to help ensure regulatory compliance.
• Validating products with inhibitory activities – false negative test results
• Use of Sterility Testing consumables
Closing date for registration will be 1 month before the actual training date and minimum of 6 registrants to start the class.
Register & enquiries
What will you be able to do after attending this course?
• Understanding and identify root causes for common handling issues
• A full set of course notes
Cost:
Course Description
• Operate the Mas100 air sampler hardware.
Environmental Monitoring School
• A full set of course notes
Venue: Plot No. Bommasandr12,a-Jigani Link Road, Industrial Area, Anekal Taluku, Bengaluru-560100.
– USP <1116>
The course is designed primary for quality control, manufacturing or quality assurance personnel who perform or responsible for the performance of Environmental Monitoring.
What will you receive?
Register & enquiries
• Verification of Mas100 air sampler operations.
+91MATLabIndia@merckgroup.com9916697979
` 15000/= per person for 2 days
• Aseptic techniques of Environment Monitoring for Air, Surface and Swab sampling.
• Selection of sampling methods.
Cost:
• Trending and Results interpretation.
• Design and Setup Environmental Monitoring program.
Course Objectives
Code: BMSCHOOL1
Who should attend?
In the hands-on practical workshop, participants will learn how to perform the different sampling methods and validation verification of the air samplers. The workshop will aid the understanding of the lecture contents with practical applications. All critical aseptic techniques in Environment Monitoring and its consequences on test results are discussed and solutions are explained. Our experienced trainers will also provide valuable suggestions to help ensure compliance to regulatory requirements.
• Troubleshoot specific user-related situations
Hands-On Practical Section
The practical section covers how to:
“Microbial monitoring programs for controlled environments should show the effectiveness of cleaning and sanitization practices by and of the personal that could have an impact to the controlled environment”
This two day course provides an in-depth review of the regulatory requirements of Environmental Monitoring, appropriate sampling methods, results interpretation and practical implementation. The course is based on the most recent editions of pharmacopeias and provides information and differences between the United States Pharmacopeia (USP) and European Pharmacopeia (EP).
• Certificate of Achievement
• Understand the current Standards and Regulatory requirements.
Closing date for registration will be 1 month before the actual training date and minimum of 6 registrants to start the class.
Date: 09 - 10 November 2022
Hygiene Monitoring & Personnel monitoring
Our Training Offerings:
Insights & Preparatory measures into Regulatory audits
BioMonitoring School
BioMonitoring School is a highly interactive microbiology certified course, designed to upgrade the aspiring professionals from Pharma and Biopharma with latest techniques, skills, methodologies, troubleshooting and strengthen knowledge in the areas of industrial microbiology analysis and related regulatory updates.
USP <1117> "Microbiological Best Laboratory Practices”
Environment monitoring in pharmaceutical clean rooms and other controlled environmentsEnvironmental monitoring - The EM master plan, methodology, regulatory expectations, data trending Compressed air monitoring
Microbiology Warning Letters
Rapid Microbiological Methods, Validation approach and implementation
Pyrogen Testing using Monocyte Activation Test
Sterility Testing & validation in Pharmaceutical Industry as per the Pharmacopeia –IntroductionUSP/EP to In-process Testing (Limit test / Microbial enumeration / test for specifies microorganisms / Bioburden test)
Culture media used for pharmaceutical application, Culture Media Preparations, Performance Testing & Trouble Shooting as per ISO-11133
Process Simulation - Media Fill Test
Merck Life Science Private Limited Plot No. 12, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluku, Bengaluru-560100. Website: www.merckmillipore.in | www.sigmaaldrich.com For more information, write to us at MATLabIndia@merckgroup.com For Registration: Click Here or Scan QR Code
