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Partnership Announcement Phamedics and CCS

 Durham NC / Ravensburg, Germany , September 14th, 2012

Phamedics Consulting is delighted to announce a strategic consulting partnership with comes compliance services. comes compliance services is a European based, highly experienced, boutique consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements.

This partnership will allow comes compliance services to continue to expand its excellent compliance services by utilizing Phamedics Consulting as partner to provide Quality & Compliance services throughout the United States especially to the Triangle region of North Carolina, the South East Pharma and Biotech corridor of the US.

The two firms compliment one another`s quality and compliance service offerings and will work together to provide clients with excellent services in cGMP compliance, Project Management, Quality Systems Improvement and Validation. 

 

About Phamedics Consulting

Phamedics Consulting is a project consulting firm focused on supporting the pharmaceutical, biotechnology, medical devices, food & beverages, clinical research, cosmetics, consumer products and other FDA regulated industries solve the complex challenges and decisions facing their company today. Phamedics Consulting offer Quality & Compliance solutions and project management consultant services to a diverse range of regulated industry clients. Please visit our website to learn more about services at www.phamedics.com

About comes compliance services

comes compliance services is a European based, highly experienced, boutique consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. At comes compliance services (CCS), we strongly believe that quality and compliance management will drive continuous improvement and performance optimization. We utilize a more proactive and risk-based approach to quality assurance and validation backed by proven expertise and electronic tools from our partners. We focus on value-added project, process and risk management to achieve regulatory compliance and inspection readiness. The following services and products are available to GMP, GLP, GCP and medical device regulated companies and suppliers:

  • Quality Management Services
  • IT Project Management Services
  • Comprehensive and risk-based validation concepts and services
  • Validation Tools for Requirements, Project, and Test Management

We invite you to explore our website and learn more about our capabilities, spectrum of services, contact information, and much more at www.comes-compliance.com and www.auditservicecenter.com .

 

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Audit Service Center – Success Story – from an Idea to a Vision to a Solution for Customers

comes compliance services started 3 years ago their service delivery package named to “Audit Service Center” (ASC) to several local and global pharmaceutical customers. To date the services are used by several pharmaceutical companies to outsource their audit management of manufacturers of materials, products, components, and services providers, in GMP, GCP, GDP, GLP regulated industries such as pharmaceuticals, biologics, medical devices, cosmetics, dietary supplements.

ASC – one of the leading external audit management service providers in Europe: How does this work? It is not only the audit execution by checklists for CCS customers or providing a web-based audit management tool, also to initiate shared audits between our customers, linking to the QPSHARE database, performing audits and also to control and monitor or even to support correction action plans.

Contact us today for more information and benefits using the ASC solution: contact@auditservicecenter.com

 

 

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New EMA Pharmacovigilance Legislation 2012 – electronic submission of information

In July 2012, the new pharmacovigilance legislation will come into effect across the European Union, according Regulation (EU) No 1235/2010External link icon and Directive 2010/84/EUExternal link icon.

According EMA this legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of European Union marketing authorisations. The European Medicines Agency is responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation is effective from July 2012.

Regulation 1235/2010 states that by 2 July 2012, marketing-authorisation holders will need to submit information to the Agency on medicinal products for human use authorised or registered in the EU using an electronic format provided by the Agency. Marketing-authorisation holders will also be responsible for maintaining this information once submitted. The European Medicines Agency is progressing with the implementation of the electronic submission of information on medicines (read more).

The Agency published the format for the electronic submission of medicinal product information in July 2011 as XML Schema Definition (XSD), submitted via the EudraVigilance GatewayExternal link icon. On 5 March 2012, the Agency published an update of the format, including detailed guidance, Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) messaging schemas, controlled vocabularies and frequently asked questions. The Agency maintains its plan to update the initial format published in July 2011 in line with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. The IDMP standards are scheduled for finalisation during the second half of 2012.

comes compliance services (CCS) offers consultancy services for the implementation road-map and integration of e-reporting and submissions based on the regulatory requirements. Contact us today for more information and our service options related to e-reporting and submissions to the agency: talk@comes-services.com

 

 

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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 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

 

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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 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

 

Read more: EMA QRM ICH Q9 

Contact us today. Or read more about our service approach and solution for test,validation, or training management at www.comes-services.com. Start your Live Proposal Request right now.

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

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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 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.

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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 network updates.