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 863-968-3219.
