January/February 2009

Theme:  Innovative Technology

Ads Close:

5 December 2008

Ad Materials Due:

12 December 2008

Publish:

21 January 2009

Bonus Distribution:

ISPE Tampa Conference, INTERPHEX, ISPE Brussels Conference.

Country Profile Feature:

China

Description:

This issue will focus on the latest trends and innovations in the pharmaceutical and biotechnology industry, including new manufacturing and packaging methods; disposables; cleaning and sterilization; facility and process design; environmental detection; new instrumentation; and analytical methods in laboratories.

March/April 2009

Theme:  Automation Solutions/PAT/Operational Excellence

Ads Close:

2 February 2009

Ad Materials Due:

9 February 2009

Publish:

23 March 2009

Bonus Distribution:

INTERPHEX Mexico, PDA Annual Meeting, INTERPHEX Asia, ISPE Chicago Training, ISPE Barcelona Training.

Country Profile Feature:

USA

Description:

Articles in this issue will focus on the automation solutions utilized in manufacturing, laboratory processes, operational excellence, and PAT. Topics include theoretical and practical applications of automation, including electronic batch record management, data warehousing, asset management, infrastructure monitoring, process data monitoring, and business process metrics.

May/June 2009

Theme: Regulatory – PQLI

Ads Close:

1 April 2009

Ad Materials Due:

8 April 2009

Publish:

22 May 2009

Bonus Distribution:

ISPE Washington Conference

Country Profile Feature:

India

Description:

Achieving global regulatory harmonization is a key objective for the pharmaceutical and biotechnology manufacturing community. Articles in this issue will address important topics influencing change in the industry, including the current status and interpretation of ICH Q8, Q9, and Q10; progress on ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative; USP, EP, and JP; consensus standards such as ASTM E55, BPE, and ISO; function and organization of regulatory bodies; and the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

July/August 2009

Theme: Utilities

Ads Close:

1 June 2009

Ad Materials Due:

8 June 2009

Publish:

21 July 2009

Bonus Distribution:

 ISPE Geneva OR Zurich Conference, China Pharm Exhibition, ISPE Dublin Training.

Country Profile Feature:

Argentina

Description:

Utility systems will be featured with case studies, new technologies, and current industry standards and guidance. Topics may include critical utilities supporting production, non-critical systems (such as electricity), energy and resource management, green initiatives, and energy efficiency. Also featured may be computer, remote and local monitoring systems commonly used in utility systems.

September/October 2009

Theme: Management of Globalization

Ads Close:

3 August 2009

Ad Materials Due:

7 August 2009

Publish:

21 September 2009

Bonus Distribution:

 ISPE Rome Conference, ISPE Annual Meeting, AAPS Annual Meeting, ISPE Delaware Valley Training.

Country Profile Feature:

Italy

Description:

Articles and case studies will focus on issues facing global manufacturing and distribution, such as quality standards, harmonization, outsourcing, logistics/supply chain issues, management of a diverse workforce, integration of equipment from global suppliers, and life cycle management of equipment from global suppliers.

November/December 2009

Theme: Integrated Commissioning and Qualification

Ads Close:

2 October 2009

Ad Materials Due:

8 October 2009

Publish:

20 November 2009

Country Profile Feature:

Spain

Description:

Articles in this issue will address opportunities to streamline and/or integrate commissioning and qualification utilizing recently issued guides, standards, and technologies. Case studies describing successful implementation of the integrated approach will be provided. Other tools to reduce qualification cycle time, such as risk assessment, will be covered.