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Online Training Sessions 2020

For the last months, Asociación Forum Auditorias (AFA) has been offering a series of webinars dedicated to different hot pharma topics. Each of these webinars makes a special treatment of the topic under the prism of AFA expertise auditors, offering the answers to the most common questions. These webinars are now available individually or in packages (with reduced price) for off-line visualization.

Manufacturers of Registered Starting Materials
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The synthesis of APIs has, in many cases, many stages before the active pharmaceutical substance is obtained.

The Drug Master File defines the part of the process that must consider compliance with GMPs and is associated with the registration of the drugs that incorporate it.

In many cases, this GMP process begins near the end and, therefore, in recent times the Health Authorities require control and audit of the stages leading to the so-called Registered Starting Materials (RSM).

Audits of RSM manufacturers have the difficulty of not having a clear regulatory framework of reference and must be carried out based on risk.

In this Webinar we will share the accumulated experience of having carried out more than 60 audits of RSM manufacturers and that will allow us to provide you with clear criteria to be able to carry out a logical and effective audit approach.

Overview about the entire API process and identification of intermediates, registered starting materials, GMP intermediates and API.

Risk criteria and identification of the risk factors and their justification.

Risk based audits methodology and performance.

Most common observations.


Target Group

Technical staff from API, and Pharmaceutical industry.


Speaker's background

Dr. Eduard Cayón - AFA Director

Ph.D. in Organic Chemistry. More than 25 years of professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry.

Since 1999, working as a Consultant for Pharmaceutical industry in TDV (www.tdvct.com ), giving services to customers from several European and Asian countries.

Founding partner, Vicepresident and Director of Asociación Fórum Auditorías (AFA) from 2005 (www.forumauditorias.org ). More than 300 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical, Chemical and Cosmetic industries.

Auditing Cleaning Activities in Pharma Plants
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Cross contamination is one of the most important risk for the patients derived form the manufacturing operations, specially in the multiproduct plants. The main risk reduction actions to be done are the cleaning of the product direct contact surfaces and their environment and therefore cleaning activities must be considered critical and very well controlled by correct design and daily execution and monitoring.

Correct implementation of cleaning activities in a pharmaceutical plant needs the involvement of different departments (R&D, engineering, QA, production, QC, etc.) and requires a correct application of different tools and procedures (risk assessment, methods design, records design, analytical methods, sampling methods, validation approach, personnel training, etc.).

In this Webinar we will share our knowledge and experience from having carried out hundreds of audits of APIs, finished products and excipients, in which evaluation of cleaning activities use to be a hot topic and should include:

Evaluation of different scenarios (facilities, equipment, processes, products, etc.)

Rational for cleaning process design.

Cleaning execution: procedures, guides/records, visual inspection.

Validation approach based on risk assessment .

Validation, revalidation and verifications.

Examples of most common observations will be shown during the webinar and it will be enabled a space for questions and answers.

Target Group

Technical staff from API, and Pharmaceutical industry.


Speaker's background

José Carlos Vergara

AFA Head of Technical Department


Master’s degree in Chemistry. With 17 years of professional experience in Quality Control, Quality Assurance, Validation and Auditing in different companies and different countries.

Integrated in TDV (www.tdvct.com) from 2016 and lead auditor in Asociación Fórum Auditorías (AFA) from 2017 (www.forumauditorias.org ). More than 60 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical and Chemical Industries.

Process Criticality Assessment & Process validation
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Proper design and development of the process, the subsequent process criticality assessment and the following process validation approach needs the involvement of different departments (R&D, engineering, QA, production, QC, etc.). Only through a rational evaluation of all this knowledge it is possible to discern the critical process parameters and design the adequate validation strategy. Process validation strategy is aimed at showing the consistency of the critical operations and process robustness between different batches produced in the final industrial scale and environment. Number of batches and extended sampling plan should be well stablished to allow checking the behaviour of the process under all the expected variables.

After this initial validation exercise, process behaviour is monitored batch to batch and reviewed, and trend analysis is performed periodically to be sure that the process is kept in the validation state.

Approach towards these topics may show differences between different actors in the pharmaceutical industry (i.e. API manufacturers, finished product manufacturers or excipients manufacturers) according to the inherent characteristics of the related processes and facilities: from batch manufacturing in multiproduct and multifunction facilities to continuous process in dedicated fit-for-purpose facilities, including legacy products and new developed products.

In this webinar we will share the accumulated experience of having carried out hundreds of audits of APIs, finished products and excipients, in which evaluation of process criticality assessment and process validation approach is a hot topic. This should include:

Overview of the technical-scientific aspects related to the process development, criticality assessment and process validation design

Brief overview about main differences in process criticality assessment and process validation between the different manufacturers within the pharmaceutical industry

Most common observations

Target Group

Technical staff from API and Pharmaceutical industry.


Speaker's background

Aina Sellés - AFA Technical Manager and Quality Assurance Responsible

Computer System validation in GxP audits
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In recent years, computerization has been a global trend and the pharmaceutical industry has not been an exception. Under the pressure of improving efficiency and in the face of challenges such as guaranteeing data integrity and traceability of the supply chain, computerisation went from being an incipient to a key element in the pharmaceutical industry.

The benefits of the introduction of computer systems in the pharmaceutical industry are clear. On the one hand, the reduction of manual and paper-based systems, a classic source of errors and less efficient than computer programs. Workflows were also facilitated, improving efficiency. Of course, with the right controls, the safety and quality of the processes was improved.

But it also introduced new challenges. The nature of information systems introduced new risks into the drug substances and drug products manufacturing processes. The ability to manipulate data, the risk of malfunction or wrong decisions taken by the system or the eventual loss of GxP data increases as the systems grew.

Regulatory agencies have not been on the outside of this process. Logically, as computerization became more important, the regulations had to be adapted to this new reality. The appearance of specific regulations such as the FDA's 21 CFR Part 11 guide or Annex 11 of the GMP, together with the latest Data Integrity guides, only confirm that information technology is already a pillar in inspections and, therefore, an element to be taken care of in suppliers audits. And what the agencies expect from the computer systems is not very different from what they expect from any other critical element: Design Review, initial Risk Analysis and periodic review, Validation and continuous control by the quality system.

In this Webinar we will share our knowledge and experience from having carried out hundreds of audits of APIs, finished products and excipients, in which evaluation of computer systems validation activities use to be a hot topic and should include:

Evaluation of the level of use of computerised system as a level of automation of the company

Understanding of the role of the computerised systems in the overall GxP compliance

Determining the Computer System Validation maturity level of the company

Examples of most common observations will be shown during the webinar and it will be enabled a space for questions and answers.


Target Group

Technical staff from API, and Pharmaceutical industry.


Speaker's background

MªÀngels San - TDV Projects Division Manager


BSc in Chemical Engineering. Her 20 years of professional experience have been developed in the fields of Fine Chemical, Pharmaceutical and Med. Device Industries, as a consultant specialized in Information Technologies, Validation and Quality Systems Implementation for life science companies. She is a qualified GXP auditor of pharmaceutical suppliers.

Supply Chain & GDP Audits
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Distribution networks for medicinal products have become increasingly complex, with the involvement of many players, especially since the rise of globalization in the 1990s.

The main problem that has arisen from this change is that the control over the logistics chain has become much more complicated, especially taking into account the characteristics of the products, which can be sensitive to heat, humidity and light in many cases.

In practice, companies’ Qualified Persons (QPs) did not have an adequate degree of control and information about what was occurring in the supply chain. However, they had to answer to the Health Authorities for incidents, and also during inspections. This is the main reason why Good Distribution Practices (GDP) were created, seeking to align requirements and facilitate compliance with regulations, always with the aim of ensuring the safety, quality and traceability of the products throughout the integrated supply chain.

At AFA, we understand the supplier evaluation process as something that goes way beyond auditing. To carry out this process as a mere formality, without strategic vision, is little less than dooming oneself to having problems in the future. These problems can be regulatory, economic and brand prestige, to name a few. The sooner the potential gaps are detected, the lower the overall cost for all the parties involved.

In this webinar we will provide about the clues to approach efficiently the audits to the players of supply chain.

Target Group

Technical staff from API, and Pharmaceutical industry.


Speaker's background

Dr. Eduard Cayon - AFA Director

Ph.D. in Organic Chemistry. More than 25 years of professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry.

Since 1999, working as a Consultant for Pharmaceutical industry in TDV (www.tdvct.com ), giving services to customers from several European and Asian countries.

Founding partner, Vicepresident and Director of Asociación Fórum Auditorías (AFA) from 2005 (www.forumauditorias.org ). More than 300 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical, Chemical and Cosmetic industries.

Efficient Data Integrity Evaluation in GMP Audits
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Data Integrity is a key element to be verified during the audits to pharmaceutical and API companies and still a big source of observations in both customer and health agencies ones. Therefore, it is necessary to conduct data integrity checks during them, but it is not possible that this activity monopolizes all the audit time. Data Integrity is not all the GMPs.

Consequently, it should be balanced the time used for data integrity checks and all the other checks in the audit, obtaining the most information for the inverted time and preventing that this topic distorts a well-planned agenda.

In this Webinar we will share our knowledge and experience from having carried out hundreds of audits of APIs and finished products, in which data integrity evaluation has been a key element. The Webinar will depict the key considerations to do an effective data integrity review, including:

Alignment of Data Integrity checks in an audit agenda

Data Integrity key points & verification strategy in manufacturing & maintenance

Data Integrity key points & verification strategy in quality control

Data Integrity governance

Tips and tricks. Running away from a well-prepared story.

Examples of most common observations will be shown during the webinar and it will be enabled a space for questions and answers.



Target Group

Technical staff from API, and Pharmaceutical industry.


Speaker's background

Sergi Arcas - TDV Software Area Manager


Chemical Engineer with 19 years of professional experience in the Pharmaceutical and API industry, as well as in the GLP/GCP areas, as consultant in TDV. Responsible of conducting hundreds of computerized system validation projects of all kinds and also tenths of Data Integrity specific audits in companies.

He is qualified as AFA lead auditor since 2008 and he has conducted around 100 worldwide audits to suppliers and manufacturers of Pharmaceutical and Chemical Industries.

APIs for parenteral use: what we should expect to find in audits
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APIs used for parenteral dosage forms, or more widely for sterile medicines, should comply with certain requirements, but these will largely depend on the subsequent use of the API and how it is involved in the manufacturing operations of the final dosage forms.

There is a huge difference between Sterile API, which should adhere to regulations and guidelines beyond ICH Q7, and non-sterile API formulated later in sterile dosage forms: parenteral, ophtalmic,…

Risk Assessment plays, once more, a key role in the identification of what our expectations should be when auditing a specific manufacturer for a specific use of the API.

In case of non-sterile API used for parenteral FDF, the main risks and therefore, the expectation to prevent them requires that the API should be pyrogen-free. In case that the FDF manufacturing process does not include a filtration step, then the API must be also free from foreign particles.

This webinar will discuss:

Different uses if API in sterile dosage forms

Formulation processes involved and related risks

Practical measures manufacturers implement to prevent risks

Our responsibilities as auditors when auditing these type of API

Target Group

Auditors of API suppliers, Technical staff of API manufacturers, and Quality Assurance personnel.


Speaker's background

Dr. Octavi Colomina - TDV CEO


PhD in Chemical Engineering and BS Sci. In Organic Chemistry. With 38 years of professional experience in R&D, Chemical and pharmaceutical Industry, Computer Sciences and Pharmaceutical Consultant and Auditor for 25 years.

Founder adn Technical Manager of TDV Compliance Technology and President of Asociacion Forum Auditorias (AFA).

Remote audits for auditors
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In this webinar we will provide the answers to the following questions:

Which is the regulatory background to be considered?

Main differences between remote and face-to-face audits?

Methodology to conduct efficient and successful remote audits.

Evaluation of the trustworthiness of the audit

The main purpose of the audits is to ensure that the audited supplier performs the operations in accordance with the agreements and regulatory requirements; these operations are carried out under a Quality System that guarantees the absence of risks for the patient.

From AFA, we provide the necessary information and conclusions to enable QPs taking objective decisions, which can also be defended and justified in front of the Health authorities.

As we have been informing you, AFA has been dynamically adapting its methodologies and procedures to the needs and possibilities to carry out audits. Bearing in mind the current evolution of the COVID pandemic and the persistent difficulties in mobility and access to the facilities of the companies to be audited, we have developed and optimised the methodology to carry out remote audits.

This methodology establishes the performance of the audit in two phases: a first phase, in which the relationship with the auditee is based on the exchange of information and documents based on requirements established for each audit, depending on the information available to us (former audits and CAPA) and the type of products and processes. At the end of this first phase, the agenda is prepared for telematic meetings that constitute the second phase of the audit.

Once completed the audit exercise, the trustworthiness of the audit is determined through a risk assessment methodology, which yields, as one of the main outcomes, the recommended period of validity of the report and the ongoing actions to carry out.

In this Webinar we will provide you real and contrasted experiences about the remote audits’ performance in an efficient way to guarantee the success.


Target Group Qualified Persons, Auditors and QA officers.


Speaker's background

José Carlos Vergara

AFA Head of Technical Department


Master’s degree in Chemistry. With 17 years of professional experience in Quality Control, Quality Assurance, Validation and Auditing in different companies and different countries.

Integrated in TDV from 2016 and lead auditor in Asociación Fórum Auditorías (AFA) from 2017. More than 60 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical and Chemical Industries.

How to receive Remote audits (auditees)
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In this webinar we will provide the answers to the following questions:

Main differences between remote and face-to-face audits

How to plan and approach to be audited remotely?

How to protect the confidential information?

Factors that impact in the trustworthiness of the remote audits

The main purpose of the audits is to ensure that the audited company performs the operations in accordance with the agreements and regulatory requirements; these operations are carried out under a Quality System that guarantees the absence of risks for the patient.

AFA has been dynamically adapting its methodologies and procedures to the needs and possibilities to carry out audits. Bearing in mind the current evolution of the COVID pandemic and the persistent difficulties in mobility and access to the facilities of the companies to be audited, we have developed and optimised the methodology to carry out remote audits and guarantee the business continuity.

In this Webinar we will provide you real and contrasted experiences about the remote audits under the auditee point of view.


Target Group Suppliers of pharmaceutical industry.


Speaker's background

Dr. Eduard Cayon - AFA Director

Ph.D. in Organic Chemistry. More than 25 years of professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry.

Since 1999, working as a Consultant for Pharmaceutical industry in TDV, giving services to customers from several European and Asian countries.

Founding partner, Vicepresident and Director of Asociación Fórum Auditorías (AFA), from 2005. More than 300 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical, Chemical and Cosmetic industries.

Auditor skills in remote / face-to-face audits
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In this webinar we will provide the answers to the following questions:

What is the impact of the auditor skills in the success of the audit?

What are the key skills to take into consideration?

What are the differences of performing remote or presential audits for the auditor?

The auditor is the centrepiece of audits, as the reliability of the audit depends largely on his or her ability to create an environment of trust, know how to focus attention on key points and have a strong ability to effectively communicate conclusions and observations, both to the auditee and to the people who must use the information from the audit to make decisions.

In this webinar we will identify the main attributes of the auditor and the skills that should be enhanced for the correct performance and reporting of audits. We will also see the differences between face-to-face and remote audits as far as the auditor is concerned.


Target Group Companies in the pharmaceutical framework


Speaker's background

Dr. Eduard Cayon - AFA Director

Ph.D. in Organic Chemistry. More than 25 years of professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry.

Since 1999, working as a Consultant for Pharmaceutical industry in TDV, giving services to customers from several European and Asian countries.

Founding partner, Vicepresident and Director of Asociación Fórum Auditorías (AFA), from 2005. More than 300 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical, Chemical and Cosmetic industries.

Pricing

Affiliates Fee Non-affiliates Fee
Webinar fee 110€* 120€*
From 3 to 5 webinars -10% discount -10% discount
From 6 to 8 webinars -15% discount -15% discount

*Applicable taxes, if any, not included