Mr. Antonio Legnani, DOC Technical Director, will deliver the following speech during the upcoming three days Proceasep 2017 Annual Conference in Cuba:
“Calificación de Extractables y Lixiviables en los materiales en proceso y las formas terminadas: Parte 1: Aspectos regulatorios. Parte 2: Caso de estudio” / “Extractables & Leachables Qualification of In-Process Materials and Finished Forms. Part 1: Regulatory Overview. Part 2: Case Study”
About Proceasep Annual Conference:
PROCEASEP se ha convertido en uno de los eventos más importantes para los especialistas y técnicos que en Cuba trabajan en la industria biofarmacéutica. Este taller es una oportunidad única de discutir con expertos de clase mundial las últimas tendencias en la producción y las regulaciones relacionadas a esta industria y una vía para saber como implementar los últimos requisitos de las BPF en nuestros procesos productivos.
For additional detail discover more on: http://www.biocen.cu/prosep/pro.html
Mr. Antono Legnani, DOC Technical Director, will deliver two speeches during the upcoming two days APIC Annual Conference:
Day 0ne – Guide to Inspection and Process review for Sterilization by Filtration, over all regulatory requirements
Day Two – Glass, Elastomers, Plastics and Polymeric Material in Pharmaceutical System: qualification approach based on recent USP regulation
About APIC Annual Conference:
The Arab Pharmaceutical Industry congress (APIC) was designed to provide an innovative and comprehensive overview of the latest research developments in pharmaceutical machinery. Our events offer a platform for professionals to share knowledge, network and discuss trend in the pharmaceutical industry. Register now to join us in a day of knowledge sharing, networking and to get a chance to meet and get to know the services of pioneers in the filed.
For additional detail please download the official brochure below
Masco Group is pleased to invite you to our Seminar, organized in collaboration with Melapack Kft. Process division dedicated to the Pharmaceutical and Cosmetic Industries.
Through the several lectures presented, it will be provided an update about the latest regulatory requirements and an anticipation about the ones that will become effective starting from 2017.
Moreover the latest technological trends related to the manufacturing of pharmaceutical and cosmetic finished products like sterile solutions, suspension and ointments will be shown through specific case studies coming from our experience.
The last part of the Seminar will be dedicated to the Quality matter and it will cover the qualification and validation aspects of material, equipment and containers in contact with the pharmaceutical drug formulation.
Entry is free, however places are limited, please register in advance to confirm your attendance.
For any additional information regarding the participation please fill the form below
Masco is organizing a 2-day-Validation seminar, which will be held in St. Petersburg, 3rd – 4th of October 2016.
The topic of the event is the following: “EU GMP NEW APPROACH: Commissioning and Qualification”.
The seminar is focused on technical and regulatory aspects of validation of a pharmaceutical facility as per the latest EU GMP Annex 15 as well as NEW EP Monograph.
On October 4th a visit to “Polysan” factory (http://eng.polysan.ru/) is organized for all participants.
For any additional information regarding the participation please fill the form below
Mr. Antono Legnani, DOC Technical Director, will deliver a speech during the upcoming Conference Day organized by PDA Italy Chapter titled:
Highlights from “Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision”
“Points to Consider for Aseptic Manufacturing – Part 1 & 2”
For subscription or for additional info click here
Mr.Paolo Curtò, DOC Managing Director, will deliver a speech during Conference Day Two focused on New EU EP WFI Monograph
Please find below the full program agenda of the day, for more info click here
8:00h – 8:30h recepção
8:30h – 9:15h
#101: Continuous Processing Manufacturing Global Strategy
Christian Schanberger – Glatt
Geisom Becker – Fette
9:15h – 10:00h
#102: “Inovação em Projetos de Instalações Farmacêuticas – Conceito Super Skids” – Conception, Construction of Superskid for Life Science Industry
Serge Tarrago – Actemium
10:00h – 10:30h coffee-break
10:30h – 11:15h
#103: Latest Innovations in Isolator Technology
Marc Suter – SKAN
11:15h – 12:00h
#104: Containment Strategies for Handling of Potent Pharmaceutical Materials
Gary Partington – Extract
12:00h – 13:30h almoço
13:30h – 14:15h
#206: Efficient, high-titer monoclonal antibody production in a fed-batch process using single-use stirred-tank and rocking bioreactor systems
Yasser Kehail – GE Healthcare Life
14:15h – 15:00h
#207: State of the art bioreactor applications for manufacturing of biological API pilot batches John Medina – Bosch
15:00h – 15:45h
#208: Manufacturing Technologies to Enable Process Intensification
Jim Neville – Merck Millipore
15:45h – 16:15h coffee-break
16:15h – 17:00h
#105: New EP Monograph for WFI Production by Membrane Processes: Regulatory & Technological Challenges for Industry
Dr.Paolo Curtò – DOC/Masco – STEQ
17:00h – 17:45h
#106: Changing production strategies- New challenges in sterile filling – Multi-use filling machines for ready-to-use nested syringes, vials and cartridges
Marc Machauer – OPTIMA Pharma
17:45h Fim do Dia 2
Be Our Guest at Booth #2D70 – Pmec Pavillion
If you want to book a meeting with our Sales Representative contact us filling the form below
CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 36,000 visiting pharma professionals over three days. 2,500+ exhibitors from 150+ countries gather at the event to network and take advantage of more than 100 free industry seminars. Every sector of the pharmaceutical market is represented under one roof, this year in a new location in Barcelona. Attending CPhI Worldwide is the most cost effective way to establish new business relationships, meet with global partners and stay updated on the latest industry trends.
- CPhI Worldwide: for pharmaceutical ingredients
- ICSE: for outsourcing solution providers, contract manufacturing and services
- InnoPack: for pharmaceutical packaging and drug delivery systems
- P-MEC: for pharmaceutical machinery, technology and equipment
- Finished Dosage Formulation: for every aspect of the finished dosage supply chain
The 2016 DOC’ training and seminar program is going ahead…
The next step will be in Spain, where DOC, in collaboration with its sister company Stilmas and its local Spanish partner IMCO, will present on 28th and 30th of June a seminar session focused on the topic of the pharmaceutical water treatment with the latest regulatory news.
Do not hesitate to contact us filling the form below or writing to firstname.lastname@example.org directly in order to take part at this event.
- 28/06 Barcelona (Hotel AC Sant Cugat)
- 30/06 Madrid (Hotel Melià av. De las Américas)
- 9.00 – 9.15 : Welcome
- 9.15 – 10.15 : Latest Regulatory Requirements and Good Engineering Practices (G.E.P.) – By Mr. Curtò, Managing Director DOC
- 10.15 – 11.15 : Current Industry Practices and Technological Trends – By Mr. Incardona, Sales Manager Stilmas
- 11.15 – 11.45 : Coffee Break & Networking
- 11.45 – 12.45 : Validation Life-Cycle of a New Systems as per latest EU GMP Annex 15 – Mr. Curtò, Managing Director DOC
- 12.45 – 13.45 : Operational and Maintenance Aspects – By Mr. Incardona, Sales Manager Stilmas
- 13.45 – 15.15 : Cocktail –Lunch
With more than 1000 visitors and the renewed sponsorship by AIFA, the 56th AFI Symposium confirms once again the great success of the past editions.
9 Scientific Session and one plenary free entrance session, workshops, dedicated meeting point and a Poster Showcase.
See you in Rimini on 8th – 9th and 10th of June 2016 !
Visit us @ booth #46
6th and 7th of June 2016
Purpose of the training:
The Training is addressed to the Professionals and Managers of the Pharmaceutical Industries involved in the Pharmaceutical Water and Steam Systems Applications as Quality Systems(Q.A. and QC), Regulatory & Validation, Pharmaceutical Engineering & Maintenance and Manufacturing(API&DosageForms). The Seminar will explore the topics “PHARMACEUTICAL WATER” & “PHARMACEUTICAL STEAM” giving a complete overview from the European Union (EDQM/EMA), from the USA (FDA/USP) as well as from the international cGMP(e.g.Anvisa,WHO, PIC/S, ecc) and sharing Stilmas-DOC international experience on Plants Inspection with all participants. The Seminar material is updated as per current early 2016 Regulatory Requirements, especially due to the New Revised EP monograph for Water for Injection planned to be released onOctober 2016.
The Training will exploreand address in detail the following aspects:
- REGULATORY REQUIREMENTS
- CURRENT DESIGN CRITERIA
- VALIDATION LIFE-CYCLE
- SYSTEMS MAINTENANCE, MONITORING & CONTROL