The document proposes the harmonization of competency certification schemes across ASEAN countries. It discusses Indonesia's existing National Standardization System for Personnel Competency (SKKNI) which includes competency standards, certification schemes, licensing of certification bodies, and traceability of the system. The proposal suggests forming an ASEAN Competency Certification Cooperation organization to frame a mutual recognition system for licensing/accreditation bodies and develop guidelines for a harmonized ASEAN competency certification system.
Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. If the device falls into a lower-risk category in Colombia (Class I or IIa), the company will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.
Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. If the device falls into a lower-risk category in Colombia (Class I or IIa), the company will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.
Piero Iamartino, EIPG Vice-President
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
LSP JMKP merupakan satu-stunya lembaga sertifikasi profesi yang bertugas memberikan sertifikat kompetensi kerja untuk personel penjamin mutu dan keamnan dalam ruang lingkup organisasi rantai pangan. Sertifikat yang dikeluarkan oleh JMKP teregistrasi Badan Nasional Sertifikasi Profesi (BNSP), sehingga kompetensi personel diakui oleh negara dan kebeterimaan secara nasional dan internasiona (menurut regulasi MRA pemerintah).
Slide ini bertujuan mensosialisasikan mengenai pentingnya kepemilikan sertifikat kompetensi yang diakui oleh Negara untuk meningkatkan daya saing, sebagai validasi, dan mendapatkan pengakuan oleh Negara (perlindungan) dalam era pasar bebas yang telah berlangsung sejak akhir tahun 2015.
Wujudkan Indonesia Kompeten.
Salam Kompeten
Piero Iamartino, EIPG Vice-President
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
LSP JMKP merupakan satu-stunya lembaga sertifikasi profesi yang bertugas memberikan sertifikat kompetensi kerja untuk personel penjamin mutu dan keamnan dalam ruang lingkup organisasi rantai pangan. Sertifikat yang dikeluarkan oleh JMKP teregistrasi Badan Nasional Sertifikasi Profesi (BNSP), sehingga kompetensi personel diakui oleh negara dan kebeterimaan secara nasional dan internasiona (menurut regulasi MRA pemerintah).
Slide ini bertujuan mensosialisasikan mengenai pentingnya kepemilikan sertifikat kompetensi yang diakui oleh Negara untuk meningkatkan daya saing, sebagai validasi, dan mendapatkan pengakuan oleh Negara (perlindungan) dalam era pasar bebas yang telah berlangsung sejak akhir tahun 2015.
Wujudkan Indonesia Kompeten.
Salam Kompeten
Presentation on ToT by Mr. Jonathan Geale, Yorkshire and Humber TVET consortium in the Special Workshop on
‘Training of Trainers: Models & Case Studies from UK’
On the occasion of the
4th FICCI Global Skills Summit 2011
Presentation given in Rochester on April 23, 2012, Toronto on December 8, 2010 and January 19, 2011 to introduce members to the new STC Certification Program launched in May 2011.
Dti pab requirements for accreditation bodiesNcmf Halal
Presentation made byOIC Cirila Boton of PAB-DTI, lectured by Uz. Abdulhadi T. Daguit of the NCMF Halal Program Office on Feb.2, 2015 @NCMF Social Hall, Central Office.
CCP Certification training Course helps you clear CCP Certification Exam. CCP Certification is an experienced practitioner with advanced knowledge and technical expertise to apply the broad principles and best practices of Total Cost Management (TCM) in the planning, execution and management of any organizational project or program. CCPs also demonstrate the ability to research and communicate aspects of TCM principles and practices to all levels of project or program stakeholders, both internally and externally. Our CCP certification Exam preparation course lets you clear your CCP Certification Exam in first attempt!
Iso 9001 lead auditor course training irca approvedIntertek Moody
Growing scrutiny toward industry's Quality Management has made conformance with ISO 9001:2008- a voluntary, internationally recognized Quality Management Systems (QMS) standard - more important than ever.
Regardless of whether you are conducting internal audits, second-party or third-party audits, the auditor training programs must meet the highest standards of professionalism. Upon completion of this program, participants will be capable of conducting internal audits, sub-contractor audits, and supplier audits. This five-day, forty-hour course is approved by IRCA, and meets all training requirements for lead auditor certification.
Improving Operational Performance Apprenticeship in Business Improvement Tech...The Pathway Group
This apprenticeship is designed to meet the needs of candidates who are starting out in their career as BI-T administration, quality control or shop floor operative as well as materials handler. The training in Business Improvement is a blend of practical experience gained by working and learning alongside experienced colleagues in the workplace. We work in partnership with employers to help develop people to meet the needs of their business and gain a recognised qualification.
Length of Qualification: 18 months
Session 8: " Exam Preparations & Recap"
Learn more about PgMP® and PfMP® and the positive impact they may have on your professional career. Both PgMP® & PfMP® from PMI could help you achieve that elusive promotion or get you that golden ticket to joining your dream organization.
The webinar will cover popular questions surrounding the certifications, the journey to obtain the certifications, the pathways to prepare, eligibility requirements, the application process, experience documentation, the audit process, exam information, fees, sample examination questions, and the standards involved.
The session presenter, Mr.Dharam Singh, is an accomplished management professional with over 27 years of experience in the IT, Telecommunication, Government, Banking, and Insurance industries with a successful track record in managing large teams in a strongly customer-focused service environment and delivering complex multiple multi-million dollar projects. As on May 2023, he has contributed to the success of 454 global PgMP®s and 115 PfMP®s from 49 countries.
Call us at U.S: +1 6502830123
email ID: info@vcareprojectmanagement.com
For any questions related to Project Management career, training, and certifications, you can book an obligation free 15 minutes session with Dharam Singh, CEO, PgMP, PfMP, PMP, RMP, ACP, PBA, DASM, DASSM, PMI-ATP by visiting https://bit.ly/2SbhTOK
You can subscribe to vCare Project Management YouTube Channel to catch future videos of our Q&A series and certification success stories: https://bit.ly/2YF0wJl
You can subscribe and follow Dharam podcasts and interviews with Project Management Experts on YouTube at https://bit.ly/2NDY8wd
Upcoming Online Mentoring Programs:
PgMP® - http://bit.ly/2oBKQXQ
PfMP® - http://bit.ly/39jOZSf
LinkedIn Study Group:
PgMP4U - http://bit.ly/2SBPwIp
PfMP4U - http://bit.ly/31P7GKR
PgMP Q&A series Playlist Link: https://bit.ly/2Yo7EvQ
PfMP Q&A Series YouTube Playlist Link: https://bit.ly/3BORnPq
E-Learning Programs: http://bit.ly/3b2HOid
Books: http://bit.ly/2oypc6E
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
1. ASEAN CERTIFICATION SCHEME HARMONIZATION A Proposal from Indonesia during The 3 rd ASEAN Ad Hoc Working Group on Progressive Labor Practice Jogjakarta, 9 – 10 September 2007 Presented by: Tetty DS Ariyanto
3. Cycle Diagram Of Lifelong Learning Lifelong learning Continual improvement Expand the competency Basic training Training in the work place Assessment in the work place Certification
4.
5.
6. NATIONAL STANDARDIZATION SYSTEM FOR PERSONNEL COMPETENCY SKKNI Control and development Standard Formulation Standar d Implementation Harmoni z a tion of Standardi zation Licensing of PCB Regulating Certification scheme HR Professional Competent Competitive Notifi c a t i on Cooperation MRA
7.
8. COMPETENCY CERTIFICATION SYSTEM AND ITS TRACEABILITY INDONESIAN PROFESSIONAL CERTIFICATION AUTHORITY PP, ISO 17011, BNSP Guidelines LEMBAGA SERTIFIKASI PROFESI PROTAP BNSP …., ISO GUIDE 65 LEMBAGA SERTIFIKASI PROFESI PROTAP BNSP …., ISO GUIDE 65 PROFESSIONAL CERTIFICATION BODY BNSP Guidelines, ISO 17024 Licensing accreditation LEMBAGA SERTIFIKASI PROFESI PROTAP BNSP …., ISO GUIDE 65 LEMBAGA SERTIFIKASI PROFESI PROTAP BNSP …., ISO GUIDE 65 ASSESSEE SKKNI certification LEMBAGA SERTIFIKASI PROFESI PROTAP BNSP …., ISO GUIDE 65 LEMBAGA SERTIFIKASI PROFESI PROTAP BNSP …., ISO GUIDE 65 verification ASSESSMENT CENTRE BNSP Guidelines, QMS Licensing Assessor ISO 19011, ISO 17024, ISO 17011 BNSP Guidelines 201 & 202 Competency Assessor BSZ, SKKNI BNSP Guidelines Licensing Assessor ISO 19011, ISO 17024, Specific Standard BNSP Guidelines Ministry and other regulatory bodies facilitation coordination
9.
10. Professional Certification Body TECHNICAL COMMITTEE* LICENSING ASSESSOR TEAM LICENSING PROCESS TO PCB √√ BNSP (IPCA) ASSIGN 5 ASSESSMEN/ RE-ASSESSMEN 3 ISSUING LICENSE CERTIFICATE 7 SURVEILLANCE 8 REPORTING ASSESSMENT 4 ASSIGN ASSESSOR 2 APPLICATION 1 RECOMMENDATION 6
11. Professional Certification Body WORK PLACE ASSESSMENT CENTRE TECHNICAL COMMITTEE* LICENSING ASSESSOR TEAM VERICATION PROCESS FOR WORKPLACE ASSESSMENT CENTRE ASSIGN 5 ASSESSMEN/ RE-ASSESSMEN 3 ISSUING VERIFICATION CERTIFICATE 7 SURVAILLANCE 8 REPORTING ASSESSMENT 4 ASSIGN ASSESSOR 2 APPLICATION 1 RECOMENDATION 6
12. Professional Certification Body CANDIDATE IN THE WORK PLACE/ASSESSMENT CENTRE TECHNICAL COMMITTEE* COMPETENCY ASSESSOR TEAM GENERIC COMPETENCY CERTIFICATION SCHEME CANDIDATE OF COMPETENCY ASSESSMENT Choose assessment centre 2 ASSIGN 6 ASSESSMENT 4 ISSUING CERTIFICATE OF COMPETENCY 8 SURVEILLANCE 9 REPORTING ASSESSMENT 5 ASSIGN ASSESSOR 3 APPLICATION 1 RECOMMENDATION 7
