The experience gained performing more than 2000 audits to any type of supplier of the pharmaceutical industry, together with the continuous training included in our Quality System, has led us to share our experience through different topics gathered in AUDIT ESSENTIALS.

Our proposal allows not only to share the knowledge that AFA has and that grows every year, but also to contribute the rich contrast between companies. Sessions allow to share experiences and discuss trending topics among participants coming from different companies.

Do you want to improve your resources and knowledge on performing effective supplier audits? THIS IS YOUR COURSE!

Reporting

Make your reports efficient and direct.

 

Audit organization

Enhance it!

 

Remote audits

What’s now? And future?

 

Registered Starting materials

Learn to approach them!

 

Atypical API

Looking for tips?

 

Water for process

Do your best!

 

Data Integrity

Assess it rapid and efficiently!

 

Computerized systems

Looking for clues in lots of paperwork

 

Cleaning methods

Dive into cleaning when auditing

 

Excipients

Learn the approach when auditing them!

 

GDPs

Why performing audits to carriers and distribution agencies?

 

Biotech

Biotech processes, learn what you need to audit!

 

Analytical Services

Strange approach? We will bring some light over it! How to approach the audits to analytical services?

 

Time management in audits

Usually running out of time? Find out the best tips!

 

Extension of the audit

Choose the MUST HAVE in your audit scope!

 

Genotoxic & elemental impurities

Which are the expectations in an audit?

 

Organization

Schedule

Barcelona,
June 29th, 30th and July 1st, 2021.

From 9:00 to 16:00h each day

Organization

Laura Mallo
+34 934 178 065
training_afa@forumauditorias.org

Venue

You can attend in both ways:

  • Online: Zoom platform
  • On-site: to be confirmed

Language

English

Speakers

Program

Plenary session (2.5 h)

“Smart audit report”. Logic and design of an audit report.

  • Objectives of the audit report
  • Qualified person views and expectations
  • Main sections and distribution of the information in the report
  • Description of observations and criticality assessment
  • Strategy for the fluent preparation of the audit report

Parallel sessions

Day 1. Block 1 (1.5 h)
1.1.A. Audit logistics and organization

  • Stakeholders of the audit. Different perspectives
  • Influence of cultural aspects
  • Sponsor’s audit requirements
  • Confidentiality agreements
  • Schedule of the audit life cycle
  • Tips and tricks for the auditors to organize the logistics
1.1.B.  Auditor skills. Auditor allocation

  • Importance of the auditor skills in the success of the audit. Key skills to consider
  • Auditor’s profile
  • Communication skills. Auditor – auditee
  • Disturbing factors
Day 1. Block 2 (1.5 h)
1.2.A Remote vs face to face audits

  • Regulatory frame for remote audits and the current pandemical scenario
  • Pros & cons of remote audits, how to overcome the cons
  • Methodology to perform or undergo remote audits keeping confidentiality
  • Assessment of Trustworthiness of the audit

 

1.2.B Audit approach and technical management

  • Audit life cycle
  • Establishing the scope and objectives of the audit
  • Collecting and assessing information prior the audit
  • Definition of the audit approach and agenda preparation
  • Conducting the audit
  • Full report
  • CAPA management

Plenary session (1h)

Trending topics and common observations in audits

  • Identification of the current trending topics
  • Examples of common observations and their criticality assessment

Parallel sessions

Day 2. Block 1 (1,5 h)
2.1.A. Data Integrity

  • Including data Integrity controls in an audit agenda
  • Data Integrity key points & verification strategy
  • Data Integrity governance
  • Tips and tricks. Running away from a well-prepared storytelling
2.1.B.  Computerised systems

  • Impact of Computerised Systems on the GMP compliance of the audited site
  • Assessing the maturity in the use of Computerised Systems in an audit
  • Practical evaluation of the Computerised Systems validation strategy and its deployment
Day 2. Block 2 (1,5 h)
2.2.A.  Cleaning methods

  • Main sources of contamination and cross-contamination
  • Severity of contamination risks according to types of processes and stages. API, Excipients and Medicines
  • Cleaning as a measure of risk reduction
  • Clues to evaluate the cleaning method and the cleaning validation approach
2.2.B.  Water for pharmaceutical purposes

  • Types of water used in pharma industry and their main uses
  • Generation & distribution of water
  • Validation of water systems
  • Strategy to audit the water system in API and FDF manufacturers
  • Common problems and their criticality
Day 2. Block 3 (1,5h)
2.3.A.  Biotech

  • Types of biotechnological products and processes we may face across in pharma context
  • Differences on GMP compliance for small molecules
  • How to identify the critical steps and operations within the process?

 

2.3.B.  Analytical Services

  • Characteristics of analytical services. Responsibilities distribution. Technical Agreements
  • Tracking the overall process from sampling to the Certificate of Analysis
  • Computerised systems (LIMS, LDAS) management
  • GMP data, electronic or paper. Data integrity

 

Plenary session (1h)

Audits of manufacturers not included in the Health Authorities (HA) inspection program

  • Identification of the operations having direct or indirect impact on the quality of the medicines
  • Identification of stakeholders not having to comply with specific regulations or certifications from HA

Parallel sessions

Day 3. Block 1 (1,5 h)
3.1.A Registered Starting Material

  • What is a registered starting material?
  • Identification of the risk factors with impact on the quality of the API
  • Audit’s purpose and related responsibilities
  • How to plan RSM audits?
  • Practical examples
3.1.B Excipients

  • Importance of the excipients as pharmaceutical ingredients
  • Profile of the manufacturers and general risks identification
  • Why to audit excipients manufacturers?
  • References and guides
  • Audit approach
  • Post audit actions and follow up
Day 3. Block 2 (1,5 h)
3.2.A Atypical API

  • Definition of atypical API and examples
  • Position of Health Authorities
  • View of the manufacturers
  • Risk based audits
  • Reporting and interpretating the results. Actions taken
3.2.B Packaging

  • Types of packaging materials in pharma industry and their criticality
  • Profile of manufacturers
  • Regulations and guides
  • Audit approach
  • Post audit actions and follow up
Day 3. Block 3 (1,5 h)
3.3.A Supply chain

  • Identify the potential players in the supply chain
  • Requirements for each type of stakeholder in the supply chain
  • Key indicators to assess during an audit
  • Rationale of the audit in management of the supply chain.
3.3.B Batches for clinical trials

  • Clinical trials perspective
  • Development stages of the drug substance and drug product
  • GMP requirements for the batches to be used in clinical trials
  • Approach of the audits to manufacturers

 

Fees

Three days

1,700 € per delegate (*)

Two days

1,200 € per delegate (*)

One day

700€ per delegate (*)
*Applicable taxes, if any, not included

Discounts

  • AFA affiliates: 20% discount
  • Members of Inspectorate: 50% discount
  • Second delegate (or more): 10% discount
  • Early bird (before May 28th): 10%

Discounts are not cumulative and only the highest discount will apply

Cancellations

>10 days before June 29th 2021 85% will be refunded

<10 days before June 29th 2021 no refund (*)

(*) Registration rights can be transferred to another delegate from the same organisation.

Registration