comes compliance services

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

CCS — Wed, 02 May 2012 07:27:35 +0000

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

CCS — Fri, 20 Apr 2012 13:28:19 +0000

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 1: Generic Drugs Overview
Lesson 2: Abbreviated New Drug Review Process

World of New Drugs (November 14, 2011)

Course Outline:

Lesson 1: Role of Office of New Drugs
Lesson 2: The Drug Review Process
Lesson 3: Biologics Review
Lesson 4: Pediatric Regulations

World of Drug Safety (April 13, 2012)

Activities and responsibilities of CDER’s Office of Surveillance and Epidemiology (OSE)

Web Site / Source: check for updates

provided by U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)

More trainings and information at www.comes-services.com

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

CCS — Tue, 17 Apr 2012 15:24:59 +0000

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 Analysis (FMEA)
Failure Mode, Effects and Criticality Analysis (FMECA)
Fault Tree Analysis (FTA)
Hazard Analysis and Critical Control Points (HACCP)
Hazard Operability Analysis (HAZOP)
Preliminary Hazard Analysis (PHA)
Risk ranking and filtering
Supporting statistical tools

Recommondations: PTS Trainings & Seminars in 2012

CCS — Tue, 17 Apr 2012 14:43:42 +0000

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 FDA guidelines, regulatory compliance, regulations, standards, and methods. Meet us there.

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

CCS — Tue, 17 Apr 2012 08:12:38 +0000

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 present the highlights of Baden-Württemberg research, the products and developments of Baden-Württemberg companies as well as articles of general interest from the life sciences area. The portal, which is updated on a weekly basis, also provides general information on the region.

comes compliance services is member of the BioLAGO e.V. network – www.biolago.org.

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

CCS — Wed, 11 Apr 2012 10:03:00 +0000

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

CCS — Thu, 29 Mar 2012 12:19:11 +0000

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 approval of the documents in a clear and straight forward manner.
discuss the wrap-around processes necessary to meet compliance requirements with these controlling type documents, such as Periodic review and Document Distribution.

GxPi works upon the principal that complex issues can be simplified to deliver long term business benefit, better efficiencies and cultural change. We achieve this through a combination of products and services designed specifically for compliance requirements in the life sciences sector. GxPi’s products, x-docs™ and x-train™, provide enterprise grade electronic Document, Content and Compliant training solutions. GxPi’s services cover all aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GDP), qualified person (QP), quality assurance (QA), and validation particularly with Computerised and Information Technology (IT) systems. (For more information, please visit www.gxpi.com )

Shared Audit Setup with QPShare

CCS — Mon, 23 Jan 2012 11:04:21 +0000

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 Association members were asked to submit data about their suppliers using standardised Excel sheets, including name, country, address as well as the relevant products (APIs and excipients). These data were used to identify those suppliers more than one QP were interested in and to inform the QPs who named the supplier in question. Based on this information the QPs had the option to set up a joint audit of the supplier, e. g. by one of the QPs or by a third party, and to share the information. The approach of this project is very similar to that of a pilot project that was initiated by different authorities (e. g. FDA, EMA, EDQM, TGA) to identify those companies more than one authority wants to inspect. As a consequence, one authority might conduct an inspection and share the results with other partners.

The QPSHARE database displays potential suppliers more than one QP is interested in. Members of the European QP Association are able to identify suppliers and the number of QPs interested in auditing the supplier. Confidentiality will be maintained as the names of the QPs will not be displayed. If a member would like to contact the QPs related to a certain supplier, a button allows the member to send an automatic message to the other QPs. Only if the QPs who receive the message are interested they may disclose their identity and contact the colleague. Read more about QPSHARE.

If a common shared audit is found the audit plan, execution and reporting might be managed and controlled by the independent Third Party of Audit Service Center at CCS.

CCS looks back on a successful 2011

CCS — Sat, 24 Dec 2011 12:29:22 +0000

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 and satisfied new customer wins in 2011 – by providing projects On-Time and On-Budget by utilizing highly competent and skilled consultants.

Our CCS Project Examples – successfully executed and finished in 2011:

Implementation and Validation of Production Systems and SCADA
Implementation and Validaton of Electronic Batch Recording Systems
Qualification and Validation of Building Management Systems
Support and Execution of PQRs and compliance programs
Validation of ERP, DMS, LIMS, QMS IT-Systems from several vendors
Training executions (public and in-house) and speaking at several GMP events
Consultancy PQM Systems: Quality Risk Management implementation
Audit and Inspection Preparations and Support, Pre-Audits and Action Plans
Production Quality Coverage and Quality on the Shop Floor concepts
Execution of Quality Periodic Reviews and Reporting / Trending
Assessments of GMP and medical device compliance
Process and Cleaning Validation for different products
Third Party Audit execution and reporting
SOP Development, Training Management, and Reality Checks
Validation and Qualification of laboratory systems
PAI support and verification, corrective actions planning
Support of Audit Programs and Concepts
Implementation and Validation of electronic deviation and CAPA systems
Annex 11 compliance checks and reporting
Validation of electronic requirements and test tools / applications
Support and Execution of Quality Remediation Plans
Implementation and Qualification of hygienic zones concepts and methods
Implementation of ICH Q9 and ICH Q10 including training

CCS joins MESA.org as member

CCS — Mon, 17 Oct 2011 20:38:58 +0000

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