This document discusses managing risk in cleaning validation. It covers regulatory background, identifying risks like residues and microbial considerations. It also discusses grouping equipment, identifying sampling methods and analytical limits. Risk management tools include defining standard operating procedures, critical process parameters, sampling sites and limits. Calculations for residue limits consider factors like minimum daily doses, batch sizes, surface areas, and safety factors.
Particle Size Determination and Raman Spectroscopic Evaluation of a Semi-soli...HORIBA Particle
Dr. Robert Lee of Particle Sciences joins HORIBA Scientific to discuss how his company uses the LA-950 particle size analyzer and XploRA raman spectrometer to characterize semi-solid dosage forms.
Established in 2012, EFRAC is a USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
Introduction to HPTLC in herbal product standardization
Standardization
Difference between TLC and HPTLC
Classification of HPTLC
Basic steps
HPTLC method validation for pharmaceutical analysis
Common mobile phases listed by increasing polarity
Presented by
P. Baba Fakruddin
Department of Industrial Pharmacy
In this slide contains Quality-by-Design in Pharmaceutical Development.
Presented by: T. MOUSAMI BHAVASAR (Department of pharmaceutics). RIPER, anantapur
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
SSARI (Spreading Smiles Across Rural India) is a social initiative by "Smile Merchants" to improve national standards of oral health in India by targeting rural part of the country, which accounts for almost 70% of India's population. It's less capital intensive, highly scalable, high-impact model has the promise to change the dental landscape, thus innovating to become the "Dental Services 2.0" model.
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Particle Size Determination and Raman Spectroscopic Evaluation of a Semi-soli...HORIBA Particle
Dr. Robert Lee of Particle Sciences joins HORIBA Scientific to discuss how his company uses the LA-950 particle size analyzer and XploRA raman spectrometer to characterize semi-solid dosage forms.
Established in 2012, EFRAC is a USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
Introduction to HPTLC in herbal product standardization
Standardization
Difference between TLC and HPTLC
Classification of HPTLC
Basic steps
HPTLC method validation for pharmaceutical analysis
Common mobile phases listed by increasing polarity
Presented by
P. Baba Fakruddin
Department of Industrial Pharmacy
In this slide contains Quality-by-Design in Pharmaceutical Development.
Presented by: T. MOUSAMI BHAVASAR (Department of pharmaceutics). RIPER, anantapur
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
SSARI (Spreading Smiles Across Rural India) is a social initiative by "Smile Merchants" to improve national standards of oral health in India by targeting rural part of the country, which accounts for almost 70% of India's population. It's less capital intensive, highly scalable, high-impact model has the promise to change the dental landscape, thus innovating to become the "Dental Services 2.0" model.
Live at http://www.sparktherise.com/projectdetails.php?pId=8497
Vote for the campaign by giving a missed call on 022-61850708.
Connect to us on ssariproject@gmail.com
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
IMPLEMENTATION OF QUALITY CONTROL PERFORMANCE CRITERIA AND APPROVED GUIDELINE...Moustafa Rezk
IMPLEMENTATION OF QUALITY CONTROL PERFORMANCE CRITERIA AND APPROVED GUIDELINES FOR UPGRADING OF CLINICAL CHEMISTRY LABORATORY PROCEDURES IN ALEXANDRIA UNIVERSITY HOSPITALS
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
Daily Production Management - 5 Tips to Maintain Stability & Exclusion of Abn...Antonius Pompi Bramono
5 tips to maintain stability & exclusion of abnormality in your daily production management by implementing 5S, Visual Control, Observing & Enforcement of Standard, Failsafe Devices and Abnormality Control.
Enthusiastic, hardworking sales professional seeking to obtain a challenging QA position providing
professional career growth in the pharmaceutical/biotech industry.
Validation by Vilegave Kailash, Shivajirao S. Jondhle college of Pharmacy Asa...Kailash Vilegave
General aspects
Validation of parenterals
Validation of tablets
component of validation,function of different departments,reasons for validation,shivajirao s jondhle college of pharmacy asangaon,validation of parenterals,validation of tablets,validation priority,vilegave kailash
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.
In this session from the Institute of Validation Technology's Validation Week Europe, Kurtis Epp and John Kandl discuss how to implement QbD to all three stages of process validation.
This session from the Institute of Validation Technology's Contamination and Control Week discusses regulatory expectations and industry drivers for aseptic cleaning and environmental monitoring, regulatory expectations for cleanrooms, and current FDA and EU expectations during inspection of sterile and aseptic operations.
In this presentation from the Institute of Validation Technology's Life Sciences Aseptic Processing, Kim Van Antwerpen discusses collecting environmental data, methods for trending, and interpreting and sharing environmental monitoring data.
Regulatory inspections have had a significant impact on the number of drug shortages and companies facing adverse regulatory actions.
Review of the inspection trends can be useful in assessing the regulatory status of your own company and help aid in the preparation for upcoming inspections. This session from IVT's Contamination and Control Week provides an in-depth, practical look at some of the recent Warning Letters and discusses current trends.
The Validation Master Plan is a a valuable opportunity to provide an overview of your company’s validation process, including organization structure, content, and planning.
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a manufacturer's gap analysis.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
This presentation from IVT's 2nd Annual Validation Week Canada covers the 2011 FDA Process validation and the subsequent statistical processes. Statistics in process validation is introduced as well as the integration with six sigma and solutions to common mistakes.
A comprehensive presentation on GMP systems and integration. This includes validations, vendor qualification, preventative maintenance, audits, CAPA, and utilization of system results.
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications. It also covers dosage form considerations and specifications for other components.