Using Quality Principles to Select, Qualify, & Control Contractors to Perform Out-sourcing Operations

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Howard, enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems"

Reduces the cost of drug development, manufacturing


•     Outsourcing, according to the FDA, involves hiring a second party under contract to perform the operational     processes that are part of a manufacturer’s inherent responsibilities.
•     Outsourcing is increasing for the safety testing, design, manufacture release testing, complaint handling,    distribution, and salvaging of expired/defective product; therefore, it now includes the entire product lifecycle.
•     Outsourcing reduces the cost of drug development, manufacturing, and marketing by providing these resources to    small startups that otherwise cannot enter the costly competitive drug and pharmaceutical marketplace. Large    corporations also benefit 
•     Along with physical resources, of course, the contractors offer regulatory, technical, quality, and design expertise but the contracting company must have expertise in these areas because regulations do not relieve them of assuring that these responsibilities are diligently executed.
•     This expertise must be supplied by well experienced personnel that have the appropriate mix of education,   knowledge, and expertise.
•     FDA regulations & guidance documents as well ICH, IMDRF & ISO standards provide oversight controls in order to    resolve the myriad of issues arising from outsourcing.

Why Should You Attend: 

As discussed above, outsourcing does not relieve the product owner responsibility to ensure that all regulations applicable to their product are followed. By attending this training, you will understand your responsibilities and how you can successfully meet FDA regulations when outsourcing functions. This course will explain how the company establishes their control system. It should be noted that is not only one function of the company responsible, but all functions just as they are part of the brick-and-mortar operation, must follow the regulatory and quality responsibilities.
•      Company must understand that they are responsible for ensuring that laws and regulations are followed.
•      A quality manual is required to establish a quality system that provides the appropriate perspective of outsourcing versus functioning the brick-and-mortar building by establishing relationships, on-site audits, monitoring and analyzing data outputs.
•      The quality agreement establishes the relationship and responsibilities between the contractor the contract giver.
•      Outsourcing control “outranks” the qualification and control of suppliers because it involves the finished product.
•      Outsourcing controls, for the most part, are equal between drugs, devices, biologicals, and other medical products.
•      For all products, the regulations state that any expertise used, such as consultants and advisors, must be qualified and experienced in the area of expertise, the activities must be documented, must have the appropriate training and experience, and all details of the properly documented.
•      Confidentiality and protection of intellectual property are major concerns when outsourcing.

Areas Covered

•            Defining and Analyzing the Outsourcing Environment. 
•            Regulatory Requirements for drugs, devices & biologicals.
•            The Resourcing Lifecycle
•            Planning for Outsourcing
•            Qualifying Outsourced Operations
•            Maintaining control --the Quality Agreement.
•            The Quality Agreement-Defined Responsibilities
•            Design and change control
•            Maintaining, remediating, troubleshooting, and improving outsourcing
•            Post-approval aspects of outsourcing
•            Quality Improvement and Resourcing

Who will Benefit

•       Quality and Regulatory Affairs Director
•       Quality Control Laboratory
•       Senior Management and Management Representatives
•       Sales and marketing, 
•       Purchasing
•       External Auditor
•       Internal Auditor
•       Quality Manager
•       Quality Assurance Manager
•       Documentation Control Manager
•       Quality Planner
•       QA Director
•       Quality Specialist
•       Quality Analyst
•       Senior Management

Industries who can attend

•          Medical device manufacturers
•          Pharmaceutical manufacturers
•          Dietary Supplements
•          Contract manufacturers  
•          Contract Laboratories
•          Food Manufacturing  
•          Computer software targeting the FDA regulated industry
•          Contract research organizations

Speaker Profile

Howard Cooper, CBA, CQM

Howard Cooper, has over 40 years experience in the pharmaceutical and medical device industry creating, implementing, managing & remediating quality systems. This experience has shown his leadership, organizing & problem-solving skills to develop quality systems from scratch or in the role of a change agent to remediate failing systems. This experience includes small and large companies operating in the US, Europe and Japan. He has worked with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals (Tablets, capsules, injectables), biologicals, monoclonal antibodies), and combination products.

He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

“I am looking forward to sharing my experience with you to help you learn and better understand quality and regulatory functions and apply them to achieve your goals”

•        Over 40 years of medical device, biological, and pharmaceutical experience in Quality and Regulatory Affairs in startups, small, medium and large corporations.
•        15 years of experience consulting & advising in Quality & Regulatory Affairs (QRAF)
•        This experience includes:
•        Quality and Regulatory Affairs supervision and management
•  &n

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