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Concept Heidelberg » Upcoming Microbiology Events

June 2018

Raw Data - Understanding, Defining and Managing - Vienna Austria
June 5
LOCATION: Vienna, Austria
SECTOR[S]: Pharmaceutical
TYPE: Seminar

The aim of this one day course is to understand what can be defined as raw data and explore the meaning of the term for manufacturing, laboratory and quality records. Is there harmonisation of US and EU GMP regulations? For example, What is a “quality decision” and what is the impact of having to define raw data for the process or......   Find out more

Data Integrity Master Class - Vienna Austria
June 6 - 8
LOCATION: Vienna, Austria
SECTOR[S]: Pharmaceutical
TYPE: Seminar

Data Integrity is one of the basic GMP principles. Multiple Data Integrity citations were reported by FDA and European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been, and will, continue be the focus of many GMP...   ...   Find out more

EP - USP and other Pharmacopoeias - Dealing with different compendial methods - Vienna, Austria
June 7 - 8
LOCATION: Vienna, Austria
SECTOR[S]: Pharmaceutical
TYPE: Training

It is important to understand the structure and the procedures of the different Pharmacopoeias. Some general chapters and the monographs of some widely used excipients have already been harmonised between the most important Pharmacopoeias, USP, EP and JP in the context of the Pharmacopoeial Discussion Group (PDG). But for a large number of......   Find out more

Microbiological Testing of Primary Packaging - Webinar
June 7
LOCATION: On line [internet]
SECTOR[S]: Pharmaceutical
TYPE: Webinar

This webinar aims at giving you a comprehensive but still compact overview about the possibilities of microbiological specifications and testing of primary packaging. It will cover: • Regulatory Expectations • Microbiological Specifications • Testing Methods Speaker: Dr Marcel Goverde, MGP Consulting For more information and......   Find out more

Pharmaceutical Water - Manufacture, Monitoring and Compliance - Prague, Czech Republic
June 12 - 13
LOCATION: Prague, Czech Republic
SECTOR[S]: Pharmaceutical, Water
TYPE: Training

The objectives of this intensive course are to enable the participants to pay optimal attention to critical issues during design, qualification and routine operation of pharmaceutical water systems. You will learn: How to meet the pharmacopoeial requirements How to find the critical design aspects in a water system How to......   Find out more

Clean Rooms and HVAC Systems - The new EU requirements for the use of multipurpose equipment - Prague, Czech Republic
June 12 - 13
LOCATION: Prague, Czech Republic
SECTOR[S]: Pharmaceutical
TYPE: Training

Objectives This course outlines the principles of planning, qualification and operation of cleanrooms & barrier systems and their associated HVAC systems in the GMP environment. Both the protection concepts and the premises for aseptic and non-sterile manufacturing will be addressed. For more information...   ...   Find out more

Sampling Strategies - Is the √N rule always the Best?
June 12 - 13
LOCATION: Vienna, Austria
SECTOR[S]: Pharmaceutical
TYPE: Training

The Course will cover the Comprehensive and Effective Sampling of Finished Pharmaceutical Products, APIs, Excipients, Package Components and Medical Devices The following issues will be addressed: Regulatory and compendial requirements around sampling Acquaintance with basic sampling distributions Classification of non-conformities and......   Find out more

Microbiology for Non - Microbiologists - Copenhagen, Denmark
June 13 - 14
LOCATION: Copenhagen, Denmark
SECTOR[S]: Pharmaceutical
TYPE: Training

This course will equip you with a basic knowledge in Microbiology You will develop an understanding for the importance of Microbiology for the quality of medicinal products You will become familiar with typical microbiological tests used in the Pharmaceutical Industry You will learn to interpret microbiological data correctly Case studies...   Find out more

GMP Compliance for Biopharmaceuticals - Berlin, Germany
June 19 - 20
LOCATION: Berlin, Germany
SECTOR[S]: Clinical, Pharmaceutical
TYPE: Training

This Education Course concentrates on regulatory and practical requirements regarding biopharmaceutical production. From clinical phases to routine manufacturing practical examples and case studies will facilitate the implementation of GMP in your daily business. The course will treat the topics of routine inspection from regulatory bodies...   Find out more


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