I focus on ensuring the safety and effective pharmaceutical, biotech, and medical device products through quality assurance system development and management.
I offer three ways to bring my experience and expertise into your company: pre-packaged solutions, mentoring, and conventional consulting.
Please review the options below and contact me regarding which works best for you.
3 Paths to a Quality Systems Program
“In-the-Box” Solution – prepackaged solutions
Type of Company or Project: The Do-It-Yourselfer. You need guidance and information, and want a template that can be used as is by adding a company name and/or self-customizing.
How it is delivered:
- Instantly downloadable and easily customizable PDFs, Word, PowerPoint and Excel Documents.
- Available as a single procedure or topic or as a complete set of quality system programs.
- Notes, suggestions, and advice are included with each procedure.
Contact with Cinta: None
Circle of Training – Mentoring
Type of Company or Project: Start-up companies or single project/process initiatives which want some training and mentoring but do not want a complete consulting engagement. This is an economical option support your current staff with the knowledge and support of a senior professional.
How it is delivered: In addition to receiving the applicable procedures from the “In-The-Box” solution(s) above, individual or group training and coaching is provided.
Learn how to
- Implement a Quality System
- Manage and maintain compliance
- Work through specific processes such as design control, risk analysis, audits, and supplier management
Contact with Cinta: Medium
Type of Company or Project: Start-ups and established companies which want a hands-on and customized approach, from setting up of a customized Quality System through development of documents for your project, to final implementation and training.
Representative, previous projects are listed below:
- Mock FDA audit
- Clinical Audit of the CRO and TMF
- Quality System Internal Audit
- Supplier Audits
- Batch Record Review and Release
- Stability Protocol and Report review, including expiration dating
- Design Control Management and Training
- Risk Analysis and Risk Management
- Validation Support
- Deviations and non-conformances
- Corrective Actions
- Complaint Management
- Recalls and regulatory compliance
How it is delivered. In addition to receiving the applicable procedures from the “In-The-Box” solution(s) above, individual and group training, hands-on work and deliverables are provided virtually or at the facility, as appropriate.
Contact with Cinta: High