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The courses are performed at your premises and will allow the attendance of all your auditing team or people involved in suppliers’ qualification.

Why?

Through our expertise, AFA proposes the content of each module (see Contents section). Despite of this, the specific content of each module will be customized according to the specific needs of your company. Additionally we will prepare specific modules for your organization in case you are interested.

The courses are designed to boost the interaction, fostering the participation of attendants to take the maximum effectiveness, knowledge transmission and experiences sharing among all attendants.

To whom?

Your staff involved in supplier’s homologation, GMP/GDP auditing teams, Sales, Logistics, etc., wishing to improve their resources and knowledge on performing effective audits to their suppliers.

Who?

The trainers will be part of AFA technical team and auditors with broad experience in GMP/GDP audits and processes.

When & Where?

The course will be organized at the premises chosen by your company, on the dates that suit you better.

Pricing

According to your request we will prepare specific quotation/contract to you, specifying the agreed contents and setting the fees according to the following criteria (assuming maximum 12 attendees):

Number of days Fee (travel expenses not included)
1 day (1 module) 2.400 €
2 days (2 modules) 4.000 €
3 days (3 modules) 5.700 €

In case of more attendants or if your needs requires different combination or number of days, specific quotation will be performed case by case.

Modules

Initially we propose general modules (1 day each) including the most relevant topics (see below). These can be developed and customized according to the expertise of your team.

• Module 1: Audit Organization, Execution & Reporting

• Module 2: GMP Audits (API, FDF, Excipients)

• Module 3: GDP Audits (Distributors and Carriers)

More information below

Module 1: Audit Organization, Execution & Reporting

Introduction

Pharmaceutical industry: current scenario

Applicable current regulations. Review of main changes in the last years

Auditing process as part of the Pharmaceutical Quality System

Audit methodology

Audit preparation and risk assessment

Audit execution. Time management

Audit reporting

CAPA plan follow-up

Auditor skills

Key aspects in the communication

Auditor’s role

Disturbing factors

Audit reporting

Reporting the definition of the audit objectives. Types of audits

Justification of “sampling” performed

Collection of key data

Audit diagnostic and conclusion

Essential parts of the report

How to process and select the information collected during the audit?

Formatting and language.

Workshop

Practical examples and discussion

Module 2: GMP Audits (API, FDF, Excipients)

Introduction

Regulatory framework EU/USA

Evolution of the requirements and GMP competence level of the manufacturers

Key compliance indicators. Where to focus the audit

Workshop

Working in groups answering key questions*

Plenary and conclusions

(*) Documents to prepare the workshop, will be sent one week prior to the course for a better preparation

Wrap-up

Documents and records

Risk Management

Exceptions management

Knowledge management

Chemical manufacturing

Pharmaceutical manufacturing

Analytical laboratories

Water systems

HVAC systems

Warehouses management

IT compliance

Validation

Excipient risk analysis

CMO contracts and responsibilities distribution

Tips to manage the time constrictions

Module 3: GDP Audits (Distributors and Carriers)

Introduction

Regulatory framework and responsibilities

Raw Materials Supply Chain characterization

Medicines Supply Chain characterization

Key compliance indicators

Workshop

Working in groups answering key questions*

Plenary and conclusions

(*) Documents to prepare the workshop, will be sent one week prior to the course for a better preparation

Wrap-up

Supply chain risk management

GDP compliance requirements for:

o API distributors

o Warehousing

o Medicines distribution

o Carriers

Technical agreements