'Performance qualification' diaporamas de présentation

Overview of Validation Requirements in Pharmaceutical Industry Kaushik Desai Chairman,

Overview of Validation Requirements in Pharmaceutical Industry Kaushik Desai Chairman, Industrial Pharmacy Division Indian Pharmaceutical Association www.ipapharma.org. A definition Where did validation come from ? Why do it ? What are the benefits ? How far do we have to go ?.

845 views • 56 slides

POLICY & PROCEDURE

765 views • 48 slides

A Seminar On Validation Master Plan(VMP) & Calibration Master Plan(CMP)

A Seminar On Validation Master Plan(VMP) & Calibration Master Plan(CMP). WWW.PARASSHAH.WEEBLY.COM. Introduction.

2.91k views • 45 slides

October 05, 2010

Audit Preparation & Compliance. October 05, 2010. Audit Preparation & Compliance. Quality Management This presentation gives an overview of the QM .We will discuss the following topics: Quality Assurance . Quality Control . Personnel, Training , Personnel Hygiene .

462 views • 39 slides

User requirements of a comprehensive ENVIRONMENTAL MONITORING software system

User requirements of a comprehensive ENVIRONMENTAL MONITORING software system. Susan B. Cleary. Current Practices. Legacy systems pre 1997 Spread sheets non-compliant In-house systems Maintenance / upgrade / Regulatory changes. Benefits of a Comprehensive System.

483 views • 32 slides

Converting S-Plus Applications into R

Converting S-Plus Applications into R. Andy Nicholls (anicholls@mango-solutions.com). Context. Context. Mango are speaking with an increasing number of customers who would like to convert their existing S+ application into an R equivalent. Why Convert an S+ Application to R?.

382 views • 32 slides

A seminar On Validation Of Ampoule Filling & Sealing Machine

A seminar On Validation Of Ampoule Filling & Sealing Machine. Department Of Quality Assurance Maliba Pharmacy College . Introduction. Validation may be defined as,

604 views • 30 slides

Result validation

371 views • 28 slides

Validation

Supplementary Training Modules on Good Manufacturing Practice. Validation. WHO Technical Report Series, No. 937, 2006. Annex 4. Validation. Part 1. General overview on qualification and validation Part 2. Qualification of HVAC and water systems Part 3. Cleaning validation

277 views • 27 slides

Performance Qualification of a vial washer

Performance Qualification of a vial washer. Contents. Introduction -DQ, IQ, OQ, PQ Performance Qualification of a vial washer. Introduction. DQ (Design Qualification) IQ (Install Qualification) OQ (Operation Qualification) PQ (Performance Qualification).

2.46k views • 25 slides

US & EU GMP Guidelines on Analytical Instrument Qualification and Related Warning Letters

US & EU GMP Guidelines on Analytical Instrument Qualification and Related Warning Letters. Overview. FDA/EU/USP Requirements and enforcement practices Examples of FDA warning letters The 4Q model for equipment qualification

1.6k views • 25 slides

Validation

428 views • 24 slides

423 views • 19 slides

SRACA QLD Annual Conference Townsville 2015

134 views • 13 slides

Heinz Goetz, Agilent Technologies Deutschland GmbH, Waldbronn, Germany

Development of New Start-up and Equipment Qualification Procedures dedicated to GPC-SEC Analysis. Contents Start-up kits Highly efficient PLgel Mixed-C or PL aquagel-OH Mixed column Ready-to-use mixtures of polymer standards Certified test sample

146 views • 1 slides