May 6-8, 2012 | Jacksonville, FL

ABOUT THE FORUM

Throughout the pharmaceutical and biotechnology industry, manufacturing operations are continually seen as an area where operating costs can be reduced, and where steps must be taken in order to maintain rigorous regulatory compliance. Given the number of high-profile cases of recalls and manufacturing non-compliance, the industry is in great need of additional training and education on how to make their operations compliant and world-class. Building upon the successful Q1 Life Science Manufacturing Forum hosted in January 2011, the 2nd Annual program will delve into greater depth in a number of topical areas; ranging from start up operations for both small and large-scale manufacturing, through to the management of security issues throughout the manufacture and distribution of the product.

With increasing scrutiny and inspections from the FDA, manufacturers continue to face challenges surrounding potential audits, audit corrections, and internal procedures developed to sustain a robust and compliant manufacturing facility. Learning from leaders in quality assurance and regulatory affairs with dozens of years of experience will be of great value to attendees, as presenters share their expertise and insight into the development and maintenance of highly compliant facilities. Sessions will cover topics related to preparations for audits; strategies for maintaining composure during audits, as well as internal programs that can be developed and conducted in order maintain regulatory readiness. Balancing the expertise of industry presenters alongside a focus on networking, knowledge share and informal discussion within the audience, the 2nd Annual Pharmaceutical Manufacturing Forum will be a must attend for industry executives.

TOPICS TO INCLUDE

• Crisis & Recovery Management Plans for Manufacturing Operations
• Launching Effective Document Control Initiatives to Reduce Operational Redundancy and Maintain Regulatory Compliance
• Enhancing Internal Technology Transfer Methodologies in the Pharmaceutical Industry
• Watson Pharmaceutical Label Strategy Best Practices
• Establishing a Supply Chain Network
• Continuous Manufacturing: A Look At How to Develop This Capability and the Challenges That May Arise
• Ensuring the Manufacturability of New Products through Collaboration between R&D and Manufacturing
• Utilizing Effective Changeover Strategies in Multi-Product Plants
• Maintaining a Mutually Beneficial Relationship with Contract Manufacturers
• Amylin’s CSP Life Cycle Process
• Integrating Multiple Development and Risk Management Models To Enhance Product Lifecycle Management of Combination Products
• Instituting Risk Management Procedures into Manufacturing Operations to Prevent Quality Discrepancies
• Navigating the Intricacies of Quality by Design Methodologies
• Decoding the Validation Process and Determining When Re-Validation Is Required To Maintain Regulatory Compliance
• Implementing Effective Internal Audit Strategies to Ensure Product Quality Compliance
• Packaging Standards to Guarantee Quality and Cost Efficiency
• Forecasting the 2012 FDA CGMP Landscape
  
  

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KEY PRESENTERS TO INCLUDE

Karunakar Sukuru
Director, Technical Operations
Endo Pharmaceuticals

Angie Green
VP Global Manufacturing, Outsourced Operations
The Medicines Company

Dave Grote
Senior Manager, Manufacturing
Amgen

And More...