Project management

project management and hands-on support, e.g. regarding:

• implementation or upgrading of quality systems
• software validation and/or process validation projects
• integration of risk management in your quality system and organization

Quality & regulatory audits

• internal audits
• mock external audits, e.g. notified body or FDA mock audits
• supplier audits
• training of auditors and auditors to be

facilitating group sessions, e.g.:

• risk analyses sessions
• problem solving sessions (regarding how to execute adequate corrective and preventive actions)
• strategy development and implementation review sessions
• management reviews

Training and workshops

Providing training and workshops in the above areas of expertise