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)

We configure in-company training sessions adapted to certain needs and areas of your company

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.

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

GMP Audit Services

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

GxP Consultancy

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

Digitalisation

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

Related Resources

CSV

GMP Design Review – A Comprehensive Guide to Ensuring Compliance from Concept to Completion

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

Blog

Mock Inspections: How to Prepare for FDA Compliance in the OTC Market

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.

CSV

Essential Guide to EU GSPR Compliance for Medical Devices

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

Cloud systems maintenance guide header image

CSV

Maintaining Cloud Systems – A Continuous Effort

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

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Case Study

New Solid dosage forms plant

The development of a project for a newpharmaceutical manufacturing plant with ourconsultants will allow you having a plant with anappropriate design to fulfill GMP requirements ...

Company News

Tim Hawkins Joins Rephine as CEO to Spearhead Global Leadership

Rephine, the experts in quality assurance (QA) and Good Manufacturing/Distribution Practice (GxP) compliance across pharmaceutical, biotech & medical device manufacturing supply chains, has announced the ...