SAVE-THE-DATE: BioPharMaXX – 2. Ulmer QM-Forum – 20. July 2012

Information for registration to this event will follow soon:

Event: 2. Ulmer Qualitätsmanagementforum

Das moderne QM-System – Risikobasierte Ansätze – Theorie und Praxis

20. Juli 2012 ab 10:00 Uhr im Ludwig-Erhard-Saal, IHK Ulm

By the cluster . . . → Read More: SAVE-THE-DATE: BioPharMaXX – 2. Ulmer QM-Forum – 20. July 2012

US-FDA: Training and Continuing Education – CDER World

US-FDA CDER offers following training courses online.
E-learning courses currently available in CDER World:

World of Compliance  (October 20, 2011)

Course Outline:

Lesson 1: Office of Compliance Overview
Lesson 2: Manufacturing and Product Quality
Lesson 3: Scientific Investigations
Lesson 4: Bioequivalence and Good Laboratory Practice Inspection Programs
Lesson 5: Enforcement Responsibilities
Lesson 6: Risk Management and Drug Surveillance

World of Generic Drugs  (October 20, 2011)

Course Outline:

Lesson . . . → Read More: US-FDA: Training and Continuing Education – CDER World

Compliance Support: QUALITY RISK MANAGEMENT IMPLEMENTATION (PIC/S Aide-Memoire PI 038-1)

CCS offers compliance program support for the planning, analysis, implementation, validation and verification of Quality Risk Management methods according ICH Q9 and Q10. 

Based on the PIC/S Aide-Memoire PI 038-1 and our best practice program approach we are able to serve our customers with a full-service package for QRM implementation.   

Risk management methods and tools: 

 
 

Basic risk management facilitation methods 
Failure Mode Effects . . . → Read More: Compliance Support: QUALITY RISK MANAGEMENT IMPLEMENTATION (PIC/S Aide-Memoire PI 038-1)

Recommondations: PTS Trainings & Seminars in 2012

Special Trainings 2012 – compliance and computer system validation by PTS:

Spreadsheet Validation; 19.06.2012 in Karlsruhe, Germany: Read more.
Computer System Validation; Annex 11, Part 11, GAMP5; 11. to 12.09.2012 in Wiesbaden, Germany: Read more.
Computer System Validation – Basics and Concepts – 20.-21.09.2012 in Olten, Switzerland: Read more.

CCS provides compliance training & best practice knowledge on EU and . . . → Read More: Recommondations: PTS Trainings & Seminars in 2012

Pharma 2.0: towards paperless production – Interview by BioPro – Baden Württemberg

Interview by BioPro – Markus Roemer – towards paperless production:

Read the interview in English here: OPEN

Read the interview in German here: OPEN

The Biotech / Life Sciences Portal Baden-Württemberg is run by BIOPRO Baden-Württemberg GmbH. Working in close cooperation with our authors from the Rhine-Neckar Triangle, STERN, Freiburg, Ulm and BioLAGO bioregions, we . . . → Read More: Pharma 2.0: towards paperless production – Interview by BioPro – Baden Württemberg

Stay updated with our CCS Android App – Install it now…

Stay updated with our CCS Android App: Download

Installation: Right-click on the download link “save target as” - save and unzip the file on your PC, transfer and install it on your Android SmartPhone.

You will automatically receive current news and information from CCS services, events, and news including our validation . . . → Read More: Stay updated with our CCS Android App – Install it now…

MS SharePoint webinar – 16th April at 14:30-15:30 GMT

 

MS SharePoint webinar – 16th April at 14:30-15:30 GMT – open link for registration: GXPI eshot ‘Great – It’s Another Webinar’ 280312

examine the setup, management and consumption of documents supporting a PQS (Pharmaceutical Quality System) according ICH Q10.
explore the management of lifecycle and control of documents (documentation and records according GMP Chapter 4).
follow the workflow and . . . → Read More: MS SharePoint webinar – 16th April at 14:30-15:30 GMT

Shared Audit Setup with QPShare

Our latest recommendation: How to find and setup a shared audit with other companies and QPs?

At our CCS Audit Service Center we do reference to the “QPSHARE” database, which is provided to the members of the European QP Association (external link). The European QP Association initiated a database comprising shared audits information between Qualified Persons.

In a first step QP . . . → Read More: Shared Audit Setup with QPShare

CCS looks back on a successful 2011

comes compliance services (CCS) in Ravensburg continued double digit growth in 2011 by serving best-practice compliance services and solutions to a wide range of  GxP-regulated companies and suppliers. Achieving high levels of customer satisfaction and meeting the expectations & project requirements require that CCS continually monitor and improve compliance strategies and concepts.  Key to our business success is the level of customer repeat business . . . → Read More: CCS looks back on a successful 2011

CCS joins MESA.org as member

comes compliance services joined the MESA International organisation: MESA (Manufacturing Enterprise Solutions Association) International is a global community of manufacturers, producers, industry leaders and solution providers who are focused on improving Operations Management capabilities through the effective application of technology solutions and best . . . → Read More: CCS joins MESA.org as member