Audit and Inspection in the pharmaceutical

  • 7-9 May 2024
  • Online
  • Italian

Training overview

The training course “Audit and Inspection in the pharmaceutical” aims to provide participants with useful tools to manage the entire audit lifecycle. In fact, the GMP Audit represents the main tool for the evaluation of a company’s compliance status and for an effective verification and improvement of the Quality Management System. There are two types of Audits: Internal and External, each with a specific purpose; the first, mandated and functional to ascertain and improve the application of GMP within the corporate organization, the second, deputed to the selection, qualification, and maintenance of a specific supplier of goods and/or services. Added to this is the Regulatory Audit or Inspection, carried out by Regulatory Bodies (FDA, AIFA, Ministries etc.) and aimed at maintaining or revoking the company’s GMP certification status for placing products on the market (MAH). The professional figure within the company’s Quality System who is designated to preside over these two types of audits is the Auditor, who represents a key figure in the Quality System.

The training course “Audit and Inspection in the pharmaceutical” will also explain you the inspector’s point of view and the critical aspects for a successful inspection outcome.

Key points of the training

  • Understand the main regulatory requirements that underlie Auditing activities
  • Learn the Audit Lifecycle process: objectives, tools and applications for an effective Audit system
  • Learn the key points to inspect during an audit to various systems
  • Regulatory inspections: trends and the inspector's point of view

09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

Program

7 May
Dr.ssa Lucia Costanzo, GMP Expert, PHARMA D&S

  • Recalls to Current Regulations EU-GMP, FDA
  • Audit Lifecycle Management and Effective Auditing Techniques
  • Examples of checklists and reports
  • Audit specific to documentation and examples of check lists
  • Audit specific to Production Departments:
  • General Part
  • Sterile Process (overview)
  • Secondary Packaging
  • Warehouse

9 May
Sessione I
Dr.ssa Angela Petrigliano Operation Manager Process & Quality, PHARMA D&S

  • Preparing and conducting audits to raw material suppliers
  • Critical aspects of monitoring and maintaining supply chain integrity
  • Preparing and conducting audits to suppliers of packaging materials: standards to apply
  • Approaches and best practices for conducting audits to Quality Control laboratories
  • Preparing an aide-mémoire for auditing a laboratory
  • Focus on critical aspects to evaluate in auditing a microbiology laboratory

Sessione II
Dr.ssa Fernanda Ferrazin, Ex- GMP Senior Inspector, Independent Pharmaceutical Consultant

  • How the regulatory inspection is handled
  • How to replicate the list of deviations and the inspection report
  • Recurring deviations in AIFA regulatory inspections
  • Discussion

The course is aimed at Auditors, Quality Assurance, Quality Control.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

Speakers

Lucia Costanzo

Lucia Costanzo

 GMP Expert, PHARMA D&S

Graduated in Pharmaceutical Chemistry and Technology in 1992 at the University of Siena, she has gained over 16 years of experience within the multinational GlaxoSmithKline, having the opportunity to cover various roles over time such as: Batch release manager in Quality Assurance, head of the chemical analysis/stability laboratory, head of the injectables production department, head of internal auditing activities. Over the years she has had the opportunity to deal with numerous inspections by regulatory bodies (AIFA, FDA, Brazil, China, Japan). She is currently involved in GMP Training activities within Pharma D&S and PEC.

Fernanda Ferrazin

Fernanda Ferrazin

Ex- GMP Senior Inspector

Graduated in Pharmacy in 1978 at the University of Rome La Sapienza, she has gained extensive experience as a GMP Inspector and as a manager in the public sector, first at the Ministry of Health where she served from 1984 to 2004, and subsequently at the Agency Italiana del Farmaco, established in 2004. From 2009 to 2013 she dealt with the safety of medicinal products (as Manager of the AIFA Pharmacovigilance Office and as alternate member of the PRAC – Pharmacovigilance Risk Assessment Committee of the European Medicines Agency EMA in London) and, from 2013 to 2015, she verified the regulatory obligations due for the updating of Registration dossiers and CTDs of medicines by MAH Companies, in particular in cases of withdrawal of GMP certifications of API and semi-finished / finished products production workshops.

Angela Petrigliano

Angela Petrigliano

 Operational Manager Process & Quality

Graduated in 1992 in Pharmaceutical Chemistry and Technology at the University of Siena, she has 30 years of professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. She began her career in 1992 in the Research and Development of the Technobiochip. Subsequently she worked in Quality Assurance at A. Menarini Industrie Farmaceutiche Riunite (Florence) and in the Corporate Quality Department of the Menarini Group from 1996 to 2000 where she gained experience in the different sectors of Quality Assurance and in Operations. From 2000 to 2009 she worked at Bayer Biologicals (Rosia – SI) where she assumed roles of increasing responsibility up to Plant Manager and Head of Operations. From 2009 to 2011 she was Qualified Person and Plant Manager at Galenica Senese. Since 2012 she has been Operations Manager Process & Quality at Pharma D&S; she is also involved in training activities within Pharma Education Center.

Register now

Early Bird 10%
Within 2 months before the start of the training
1260€
1400€
Early Bird 5%
Within 1 month before the start of the training
1330€
1400€
Full price

1400€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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