Client Services

I focus exclusively on cleaning technologies and cleaning validation for process manufacturing equipment in pharmaceutical manufacturing and other regulated manufacturing industries. The consulting services I offer include the following:

• Selection of cleaning processes (SOPs), including the cleaning agents, cleaning methods, and process parameters so that the SOPs are effective and validatable
• Writing or reviewing validation protocols, including selection of worst case conditions, residue limits, analytical methods, and sampling methods
• Determining effective grouping strategies to achieve a more cost effective cleaning validation program
• Writing cleaning validation master plans
• Assisting in responses to 483’s or other regulatory actions related to cleaning validation
• Auditing of existing cleaning validation programs
• Providing expert opinion on quality issues regarding cleaning process deviations
• Reviewing your cleaning program for validation confirmation as part of the “revalidation” process
• Troubleshooting difficult or intractable cleaning problems
• Developing procedures for non-routine and preventive maintenance cleaning operations
• Training your professional staff on principles and practices of cleaning and sanitizing technologies
• Training your professional staff on principles and practices of cleaning validation
• Training your production operators on GMPs and validation practices as they relate to cleaning

In addition, for suppliers of products and services to the pharmaceutical industry, I offer market research and consultation services to properly assist in product or service design to meet the needs of the pharmaceutical industry.

Services are offered on a fixed price basis (for a defined project) or on a “daily cost plus expenses” basis. To contact me about an opportunity to help your cleaning validation efforts, please click here or contact me at 865-932-6927