Alexander Montaña Barreto Email & Phone Number

Vienna, Austria

Wien, Österreich

Organon D-A-CHSupport in the course of the following QMS activities: o Quality management system o Product quality complaints o Computerized systems with impact on quality o Documentation and training o Audits and self-inspections o Deviations / CAPAs / Change management / Learning Platform / Product Quality Reviews

Vienna, Austria

• Creation, implementation and updating of QMS documentation (SOPs)
• Evaluation and validation of manufacturers, suppliers, distributors and partners
• Recording and processing of complaints, changes, deviations, OOS and CAPAs
• Solving due diligences and quality requests from partners

Bogotá D.C. Area, Colombia

• Managing regulatory processes for marketing authorisation submissions, renewals and amendments before Colombian Regulatory Authority (INVIMA)
• Performing inspections of imported products for their release on the market
• Reviewing and coordination of artworks

Bogotá D.C. Area, Colombia

• Reviewing, submission and updating necessary regulatory documentation for product registrations or renewals before Colombian Regulatory Authority (INVIMA)
• Coordinating artwork development and revision for submission purposes

Bogotá D.C. Area, Colombia

To perform Activities of Collective Interventions Plan in the District Capital: to make Inspection, Surveillance and Control (IVC) visits to all distributing establishments of pharmaceutical products, make tonnage of record narcotic medications, carry out sampling for microbiological-physicochemical analysis and consolidate and analyze results information.

Bogotá D.C. Area, Colombia

Onsite Assistance and Training to druggists Affiliates and their dependents in Technical and health aspects and current legal regulations in Establishments Independent Pharmaceutical (Drug stores and pharmacies) in Bogotá, Cundinamarca and at a National level. Participation in the Health Sector Reunions - Update of the Functional Pharmaceutical Map).

Bachelor Of Pharmacy - Bpharm, Pharmacy, Bachelor

Good Distribution Practices - France And Europe, Pharmacy

* Master the standards applicable to good wholesale distribution practices * Master the different statuses of pharmaceutical.

Das Österreichische Medizinproduktegesetz Und Die Eu-Medizinprodukteverordnungen

Anforderungen an Hersteller, Handel und Betreiber

Zertifikat Modul Ii - Kundenaudits & Behördeninspektionen: Das Qms (Quality Management System), Pharmaceutical Sciences

Zertifikat Modul 1: Quality & Gmp Des Zertifikatsprogramms "Pharma-Fachkräfte Der Zukunft", Pharmaceutical Sciences

Activities and Societies: Seminar 1 und Seminar 2 des Moduls wurden im Selbststudium absolviert. Seminar 1: Qualitätsmanagement im GMP.

Live Online Seminar, Gmp Basis-/Einstiegsschulung + Aufbausschulung

GMP Basic/Initial Training + Advanced Training. June 2021.

Grundkurs, Erste-Hilfe-Grundkurs

Activities and Societies: Ausbildung für betriebliche Erstehelfer gemäß §26 ASchG, §31 BauV und §40 AStV Praxisanteil und E-Learning.

Ausbildung Zur Sicherheitsvertrauensperson, Gemäß § 10 Arbeitnehmerinnenschutzgesetz

Activities and Societies: Seminar vom 17.11.2021 bis 19.11.2021 online im Ausmaß von 24 Unterrichtseinheiten teilgenommen. Die Ausbildung.

Training Of Internal Auditors In Quality And Good Manufacturing Practices., Auditing

Training of Internal Auditors in Quality and Good Manufacturing Practices - Participation as an assistant. Grupo Terrafarma, Mexico City..

Gdp In Switzerland, Sales, Distribution, And Marketing Operations, General, One Day Course

EU regulations and their implementation in Switzerland, Tasks, and responsibilities. Workshop: Storage and Transport: Practical Aspects.

Iso 13485: 2016 Medical Devices

Activities and Societies: ISO 13485:2016 Medical Devices - Participation as an assistant. Pharmacists Association “AQFBC” Bogotá and.

Biological And Biotechnological Drugs, Pharmacy, Assistant

Course of Biological and Biotechnological Drugs - Participation as an assistant. Pharmacists’ National College of Colombia. Bogotá DC..

Narcotics Medications. Regulations And Current Issues, Pharmacy

Narcotics Medications. Regulations and current issues - Participation as an assistant. Pharmacists Association “AQFBC” Bogotá and.

Biosimilar’S Course, Pharmacy, Assistant

Biosimilar’s Course. Participation as an assistant. Pharmacists Association “AQFBC” Bogotá and Cundinamarca. October 2016.

Seminar On Regulatory And Technical Aspects Related To Bioequivalence In Latin America., Pharmacy, Assistant

Seminar on Regulatory and Technical Aspects related to Bioequivalence in Latin America. Participation as an assistant. National Institute.

Price Regulation Of Medications In Colombia And Medications Price Information System “Sismed”, Pharmacy, Assitant

Price regulation of Medications in Colombia and Medications price information system “SISMED” - Participation as an assistant. Pharmacists.

Biopharmaceutics Classification System (Bcs) And Its Application In The Regulatory Field, Pharmacy, Assistant

Activities and Societies: Course "Biopharmaceutics Classification System (BCS) and its application in the regulatory field and in the.

Management Of Health Registrations For Medications, Pharmacy, Assistant

Course "Management of Health Registrations for Medications" - Participation as an assistant. Pharmacists Association “AQFBC” Bogotá and.

Successes And Failures In Processing Records Of Phytotherapeutic And Dietary Supplements, Pharmacy, Assistant

Course "Successes and failures in processing records of phytotherapeutic and dietary Supplements" - Participation as an assistant..