Quality GMP Auditing

GMP Auditing should not only be a basic requirement according to cGMP or general expectation, Auditing needs to add value:

Auditing should allow reflection on own weaknesses and at the same time open a corridor for improvements. Our GMP audits follow this basic philosophy to ensure a maximal quality effect for the organization.

Our objective and globally conducted GMP audits can be adjusted to your needs and requirements, they might be typical on site audits of a few days, or can be deeper operational investigations. Our main focus is on GMP-Auditing of sterile and non-sterile APIs, Finished Drugs and medical devices (as ISO 13485 auditor).

Health Authority Inspection preparation programs and support

Health Authority inspections and their preparation require discipline on all levels of an organization. Discipline to establish a readiness program upfront, allowing timely execution and confidence in people doing the right thing at the right time. Inspection preparation programs are typically team exercises and require not only technical project- and quality management skills, but foremost appropriate interpersonal skillset.

We have specialised in Health Authority Inspection support of the leading regulators in the Pharmaceutical industry and have been involved in several US FDA, MHRA, ANVISA or national European HA Inspections.

We will be happy to assist you in establishing and executing your Readiness project.

…and as after an inspection is before an inspection, let’s ensure continuous readiness.

Auditor awareness Training

Understanding an auditor’s or inspector’s mind and to follow the direction of their questions and requests is good. Better is however, to anticipate an auditor’s next step and to foresee the direction in which the audit / inspection might develop.

Our auditor awareness workshops focus exactly on this – be already one, two steps ahead of the auditor or inspector, anticipate the direction they are moving to and early understand the concerns they might have.

Our auditor awareness workshops are on-site and with your teams to ensure maximum benefit for every participants. These workshops follow a clear methodology, but can easily be adapted according to your organizational setup and need.

GMP Training

GMP requirements sometimes may feel a bit theoretical if not established already in a daily routine. In fact they are very tangible and allow a great spectrum of compliance – there is one standard and literally a 1000 ways to comply.

Our GMP trainings create sensitivity for the topic through practical examples, sharing of experience and are embedded into a dynamic, vivid style of presentation.

Our trainings can be hold as on-site training in your environment, workshops at off-site events or webinar sessions – you define the framework.