Kenosha, WI –– March 26, 2010–– Regulatory Compliance Associates Inc., a consulting firm specializing in providing technically-driven solutions to compliance-related challenges for the pharmaceutical, medical device and biotechnical industries is pleased to announce their presentation block at the 2010 MD&M East conference.

The initial module, Strategies for Warning Letter Response and Remediation, will discuss an overall approach to warning letter response and remediation, which will be followed by five supporting modules that will provide keys for success in addressing common areas of deficiency. The modules will be presented by RCA employees, along with a few RCA clients co-presenting throughout the presentation block. Listed below are the five supporting modules, which will be followed by an open panel discussion.

• Risk-Based Validation Planning and Execution


• Quality System Remediation


• Complaint Handling and Adverse Event Reporting


• DHF Remediation for Legacy Products


• Creating and Maintaining Effective SOPs and Cost Effective Training

RCA would also like to recognize Valerie Welter, Director of Quality Compliance and Sterility Assurance for RCA, for being featured as an author of Cleaning and Cleaning Validation: Volume I, edited by Paul Pluta and published by PDA. Valerie’s extensive knowledge in validation has become a benchmark of quality at RCA and contributed to her success in authoring, Manual Cleaning Processes and Procedures, the final chapter in, Cleaning and Cleaning Validation: Volume I. Valerie continues to use her experience as an influential resource to RCA and the entire regulated industry.

To obtain further information regarding RCA, call (262)-842-1250 or visit www.rcainc.com.