Concept Heidelberg » Upcoming Microbiology Events

Modern Microbiology Laboratory

Date: Sep 11 - Sep 13
Location:Hamburg, Germany
Sector: P
Type: Training

Most tests applied in microbiological QC are described in detail in the different Pharmacopoeias (e.g. EP, USP, and JP). These methods are regarded as being validated – but not

GMP for Beginners in Sterile Manufacturing

Date: Oct 09 - Oct 10
Location:Berlin, Germany
Sector: P
Type: Training

Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products and medical devices.

In the manufacture of sterile medicinal products,

Process Validation in the light of the revised Annex 15 and FDA Requirements - Berlin, Germany

Date: Oct 10 - Oct 11
Location:Berlin, Germany
Sector: P
Type: Training

With publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires a new direction.

Validation is now a "Life Cycle Process" with 3 stages:<

Process Simulation/Media Fill - Berlin, Germany

Date: Oct 11 - Oct 12
Location:Berlin, Germany
Sector: P
Type: Training

In the aseptic processing of medicinal products, product quality usually cannot be ensured by means of lab controls of the final product. Process validation by means of media fills is

Handling OOE and OOT Results

Date: Oct 29 - Oct 30
Location:Berlin, Germany
Sector: P
Type: Training

The ECA Working Group on Analytical Quality Control was founded in 2010 in order to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT