№ files_lp_3_process_7_013444
File format: docx
Character count: 19616
File size: 64 KB
This document outlines the guidelines for adverse event reporting for outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
Year:
2015
Region / City:
United States
Topic:
Adverse Event Reporting, Drug Compounding, Outsourcing Facilities
Document Type:
Guidance
Organization:
U.S. Department of Health and Human Services, Food and Drug Administration
Author:
U.S. Food and Drug Administration
Target Audience:
Outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act
Period of Validity:
Ongoing
Approval Date:
November 27, 2013
Revision Date:
June 10, 2015
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / City:
Europe
Topic:
Third party risk management, outsourcing guidelines
Document type:
Consultation paper
Organization / Institution:
European Banking Authority (EBA)
Author:
Jakub Stolarczyk
Target audience:
Financial institutions, regulators
Effective period:
2025
Approval date:
N/A
Amendment date:
N/A
Year:
2020
Regulator:
Central Bank of Ireland
Subject:
Outsourcing critical or important functions
Document Type:
Notification Form
Applicable Legislation:
European Union (Payment Services) Regulations 2018; European Communities (Electronic Money) Regulations 2011; Directive (EU) 2015/2366
Intended Users:
Payment institutions and electronic money institutions
Submission Method:
Email to Central Bank of Ireland
Deadline:
Prior to proposed changes to outsourcing arrangements
Year:
2025
Region / City:
Bangladesh
Subject:
Procurement of Physical Services
Document Type:
Tender Document
Institution:
Bangladesh Public Procurement Authority (BPPA)
Author:
BPPA
Target Audience:
Procuring Entities, Tenderers
Validity Period:
November 2025
Approval Date:
November 2025
Date of Amendments:
N/A
Year:
2026
Regulation:
EU General Data Protection Regulation (GDPR)
Type of Document:
Annex to contract / Data processing agreement
Parties:
GIZ (controller), Contractor (processor)
Content:
Clauses 1–11, Appendices I–III
Appendices:
Appendix I – Description of processing, Appendix II – List of Subcontractors, Appendix III – Technical and organisational measures
Scope:
Processing of personal data on behalf of GIZ
Legal Basis:
Article 28(3) and (4) GDPR
Sensitive Data:
Personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data, health data, sex life or sexual orientation, criminal convictions and offences
Data Transfers:
Subject to Chapter V GDPR provisions
Year:
2016
Region / city:
European Union
Subject:
Data protection, outsourcing, personal data processing
Document type:
Agreement
Organization:
GIZ
Author:
GIZ, Contractor
Target audience:
Data protection officers, legal teams, contractors
Duration:
Undefined
Approval date:
27 April 2016
Date of changes:
N/A
Context:
Legal document detailing the outsourcing of data processing under GDPR, establishing terms for data security and processing compliance.
Year:
2025
Award Program:
SSON Shared Services & Outsourcing Impact Awards
Award Category:
Automation Impact Award
Region:
North America
Application Deadline:
September 5, 2025
Finalist Announcement:
September 22, 2025
Winners Announcement:
October 21, 2025 (SSOW LATAM Bogota)
Organizing Body:
SSON / IQPC
Document Type:
Award Application Form
Subject:
Strategic Automation in Shared Services and GBS
Eligible Applicants:
Shared Services Centers (SSC) / Global Business Services (GBS) organizations
Judging Process:
Panel of industry practitioners with unanimous decision required
Submission Method:
Email submission of completed application form
Restrictions:
One entry per company per category; no additional documents; no PowerPoint or video submissions
Consent Requirement:
Publication and promotional consent for finalists and winners
Scope Requirement:
Initiative must relate to achievements from the past year
Year:
2025
Region / City:
Australia & New Zealand
Event Type:
Conference Agenda
Organizer:
Shared Services & Outsourcing Week (SSOW)
Target Audience:
Business services and shared services professionals
Date:
13 May 2025
Key Topics:
Global Business Services (GBS), shared services transformation, AI automation, intercompany processes, workforce development
Speakers:
Melissa Guy, Praveen Sasidharan, Pratik Mukherjee, Kartik Jayaraman, Abhi Kadian, Tim Johnson, Yaseen Mubarak, Mike Goldsworthy, Arturo Reitz, Jasjit Singh Kang, Jason Gonce, Graeme Henley, Dion Appel, Dr Kym Davis, Reza Akbari, Lisa Seary
Sessions:
Keynotes, panel discussions, interactive discussion groups, boardroom sessions
Year:
2026
Region / City:
United States
Industry:
Outsourcing, Pharmacy
Document Type:
Contact List
Organization:
Various Registered Outsourcing Facilities
Author:
Not specified
Target Audience:
Industry professionals, Regulatory bodies
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2026
Region / City:
United Kingdom
Topic:
Cloud outsourcing regulations
Document Type:
Regulatory guidelines
Organization / Institution:
Financial Conduct Authority (FCA), Prudential Regulation Authority (PRA)
Author:
Baker & McKenzie
Target Audience:
Financial institutions, regulated entities, cloud service providers
Effective Date:
31 March 2022
Modification Date:
Not specified
Related Legislation:
EBA Outsourcing Guidelines, MIFID Organization Regulation, Financial Services and Markets Bill
Critical Third Parties:
Not specified
RFP Number:
IMA/SSD/JB/2023/169
Issuance Date:
December 22, 2022
Deadline for Responses:
January 10, 2023
Last Date for Questions:
January 4, 2023
Anticipated Award Date:
January 15, 2023
Anticipated Start Date:
February 1, 2023
Anticipated End Date:
September 30, 2023
Contract Type:
Fixed Price Contract
Location:
South Sudan
Duty Stations:
Juba and other counties across South Sudan
Issuing Organization:
IMA World Health – South Sudan
Parent Organization:
Corus International
Reporting To:
Human Resource Manager
Type of Consultant:
Firm
Objective:
Recruitment and secondment of qualified health workers for IMA-supported facilities
Services Required:
24/7 Family Planning, Maternal, Neonatal, Child Health and Nutrition services
Legal Compliance:
South Sudan labor law provisions
Submission Method:
Email to [email protected]
Language Requirement:
English
Ethical Standards:
Compliance with Corus International procurement ethics and anti-bribery policy
Attachments:
Small Business Certification Form; Proposal Cover Page; Budget Template; NDAA Vendor Compliance Form; Disclosures
Year:
2021
Region / City:
Hong Kong, Asia Pacific
Theme:
Outsourcing, Business Process Management
Document Type:
Case Study
Organization / Institution:
Green Cherry Enterprises
Author:
John Leung
Target Audience:
Business professionals, CTOs, outsourcing managers
Period of validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Note:
Contextual description
Year:
Not specified
Region / Location:
Not specified
Subject:
IT Outsourcing Services
Document Type:
Statement of Work (SOW)
Organization / Agency:
DIR Customer / Agency
Author:
Not specified
Target Audience:
Vendor and Agency staff
Period of Performance:
One year from [Insert Date] with option to extend up to three additional one-year periods
Date of Approval:
Not specified
Key Deliverables:
Managed services, project plan, weekly reports, transition plan
Service Level Agreements:
Security, quality, availability, performance, meantime to resolution, business continuity, required communications, required documents, data quality, reliability, consistency, acceptable usage, retirement of previous software or services
Engagement Components:
Scope, roles and responsibilities, acceptance criteria, schedules, assumptions, constraints, risk management, change control
Year:
2026
Region:
Global
Subject:
International Trade and Firm Strategy
Document Type:
Educational Textbook Chapter
Institution:
University-Level Economics Curriculum
Author:
Not specified
Target Audience:
Economics students and researchers
Period Covered:
Contemporary global economy
Key Concepts:
Internal economies of scale, imperfect competition, product differentiation, international trade, multinational enterprises, outsourcing, export strategy
Year:
2024
Region / City:
Pakistan
Topic:
Research and Consultancy
Document Type:
Request for Proposal
Organization:
Research, Regulatory Insight & Advocacy Assistance for SMEs (RRI&A), Small & Medium Enterprises Development Authority (SMEDA)
Author:
Project Director, RRI&A
Target Audience:
Eligible Individual Consultants
Period of Validity:
Submission Deadline Not Mentioned
Date of Approval:
May 6, 2024
Date of Amendments:
Not Provided
Year:
2022
Region / City:
Lewisville, TX
Topic:
Education, Scholarships
Document Type:
Scholarship Application
Organization:
Cups Jars Vessels
Author:
Not specified
Target Audience:
High school seniors planning to attend college or university
Period of Validity:
Applications accepted February 1, 2022 – March 31, 2022
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2007
Note:
Region / City
Subject:
Internal Audits, Good Manufacturing Practices
Document Type:
Standard Operating Procedure
Target Audience:
Employees involved in internal audits
Year:
2021
Region / City:
Nairobi, Kenya
Subject:
Cosmetics, Safety Requirements
Document Type:
Standard
Organization / Institution:
Kenya Bureau of Standards
Author:
Kenya Bureau of Standards
Target Audience:
Manufacturers, Regulators, Consumer Protection Bodies
Effective Period:
Upon declaration as mandatory
Approval Date:
September 2021
Amendment Date:
Not specified
SUMMARY REPORT OF THE 27TH ASEAN COSMETIC COMMITTEE MEETING, BANDUNG, INDONESIA, 16-17 NOVEMBER 2017
Year:
2017
Location:
Bandung, Indonesia
Topic:
ASEAN cosmetic regulation and committee meeting
Document type:
Meeting summary report
Organizing body:
ASEAN Cosmetic Committee (ACC)
Participants:
Delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Viet Nam, ASEAN Secretariat, ASEAN Cosmetic Association (ACA)
Chairperson:
Mrs. Narupa Wongpiyarattanakul
Vice Chairperson:
Dr. Nguyen Van Loi
Agenda items:
Adoption of agenda, business arrangements, ASEAN economic integration updates, follow-up from previous ACC meeting, progress on ASEAN Cosmetic Directive implementation, industry updates, post-market alert system
Annexes:
Annex 1–9 containing delegate list, speeches, activity programs, progress reports, and ACA action plan
Key focus:
Implementation of ASEAN Cosmetic Directive, online notification systems, industry training, and post-market surveillance
Year:
2023
Region / City:
East Africa
Topic:
Cosmetics Regulations
Document Type:
Regulatory Framework
Author:
East African Community (EAC) Secretariat
Target Audience:
Manufacturers, Distributors, Regulators
Period of Validity:
Ongoing
Approval Date:
November 24, 2023
Amendment Date:
December 15, 2023
Year:
2009
Region / City:
European Union
Topic:
Cosmetics Regulation
Document Type:
Notification Form
Organization / Institution:
Competent Authorities
Author:
Not specified
Target Audience:
Competent Authorities, Responsible Person, Distributors
Validity Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified