In-Company Training

Customised Courses and Training Plans

 

In-Company Courses

The in-company courses we offer cover both basic GxP concepts for new staff, and very specialized sessions aimed at experienced staff, related to regulatory developments or industry trends. In order to get the maximum benefit, these courses are personalized in each case to the real situation of each organization or to the level of knowledge of those attending the sessions, reviewing the quality indicators, pending CAPA and, in general, identifying the aspects to be improved in each case.

Most of the courses we carry out could be included in one of the following categories, just let us know your needs and we will offer you a tailor-made solution.

What Rephine Offers

Good Distribution Practices (GDP)

Medical Devices Software Validation

Medical Devices

Good Clinical Practices (GCP) and Good Laboratory Practices (GLP)

Cleaning Validation

Process Validation

Commissioning & Qualification

Cloud Systems: New Challenges in IT Systems Validation

Advanced Computer Systems Validation

Computer Systems Validation (CSV)

Data Integrity

Elemental Impurities

Quality Metrics

Preparation of Product Quality Review (PQR) Reports)

GMP Audits

Preparation for EU/FDA inspections

Root Cause Analysis


ICH Q8&Q11 – Development of Pharmaceutical and Drugs Substances

ICH Q9 – Quality Risk Management. Risk Analysis Standards and Techniques

ICH Q10 – Pharmaceutical Quality System

Advanced Good Manufacturing Practices (GMP)

Basic Good Manufacturing Practices (GMP)

GxP Consultancy

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

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Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

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GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

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GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

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Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

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Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
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GMP Chapter 22 Adapting to Hybrid Documentation Standards