The Controls for Outsourcing Manufacturing and Testing - by Compliance Global Inc.
This webinar will begin with give a review about the importance of quality systems. Outsourcing will be defined and examples throughout the FDA approved industry will be discussed.
New Hyde Park, NY, November 07, 2015 --(PR.com)-- Overview
"The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/Procurement, Finance, and Senior Management.
This webinar will study the outsourcing lifecycle and its impact on the organization. Although outsourcing as a whole will be studied, the emphasis will be on contracting manufacturing, design, and testing.
The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA approved industry will be discussed. Of course, regulatory compliance requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance of understanding the differences between contractors and suppliers.
The process of auditing and qualifying contractors and assuring compliance quality goals are maintained, will be explained.
Why Should You Attend
This webinar will help you understand your responsibilities when outsourcing so that the product maintains its integrity and quality and satisfies customer and user requirements.
The FDA is closely scrutinizing these activities to assure that responsibilities outlined in the regulations and guidance is clearly defined between the contractor and its client.
These industry requirements are given in CFR Part 211.22(a), ICH Q7A 2.22-8, ICH Q7A 16, ICH-Q10 and Part 820, Subpart E.
The FDA has begun to more closely scrutinize the control of outsourcing because they have observed a frequent pattern where the firms allow contractors to completely control QA responsibilities.
Areas Covered in this Webinar
The Resourcing Lifecycle
The Quality Agreement-Defined Responsibilities
Design and Change Control
Maintaining Control and Problem solving
Post-approval aspects of Outsourcing
Quality Improvement and Resourcing
Covering the loopholes
Learning Objectives
Defining and Analyzing the Outsourcing Environment
Regulatory Requirements For Outsourcing - Drugs & Devices
Outsourcing Management
Who Will Benefit
Regulatory Affairs Personnel
Purchasing, Procurement, Outsourcing Department Staff
R&D Professionals
Quality Professionals
Senior Management
Level
Beginner
For registration: www.complianceglobal.us/product/700228
About Compliance Global Inc
Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.
Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.
Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
"The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/Procurement, Finance, and Senior Management.
This webinar will study the outsourcing lifecycle and its impact on the organization. Although outsourcing as a whole will be studied, the emphasis will be on contracting manufacturing, design, and testing.
The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA approved industry will be discussed. Of course, regulatory compliance requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance of understanding the differences between contractors and suppliers.
The process of auditing and qualifying contractors and assuring compliance quality goals are maintained, will be explained.
Why Should You Attend
This webinar will help you understand your responsibilities when outsourcing so that the product maintains its integrity and quality and satisfies customer and user requirements.
The FDA is closely scrutinizing these activities to assure that responsibilities outlined in the regulations and guidance is clearly defined between the contractor and its client.
These industry requirements are given in CFR Part 211.22(a), ICH Q7A 2.22-8, ICH Q7A 16, ICH-Q10 and Part 820, Subpart E.
The FDA has begun to more closely scrutinize the control of outsourcing because they have observed a frequent pattern where the firms allow contractors to completely control QA responsibilities.
Areas Covered in this Webinar
The Resourcing Lifecycle
The Quality Agreement-Defined Responsibilities
Design and Change Control
Maintaining Control and Problem solving
Post-approval aspects of Outsourcing
Quality Improvement and Resourcing
Covering the loopholes
Learning Objectives
Defining and Analyzing the Outsourcing Environment
Regulatory Requirements For Outsourcing - Drugs & Devices
Outsourcing Management
Who Will Benefit
Regulatory Affairs Personnel
Purchasing, Procurement, Outsourcing Department Staff
R&D Professionals
Quality Professionals
Senior Management
Level
Beginner
For registration: www.complianceglobal.us/product/700228
About Compliance Global Inc
Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.
Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.
Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Contact
Compliance Global Inc
Roger Davis
+1-516-900-5515
https://www.complianceglobal.us/product/700228
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Fax: +1-516-900-5510
Roger Davis
+1-516-900-5515
https://www.complianceglobal.us/product/700228
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Fax: +1-516-900-5510
Contact
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