- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this webinar experience. Questions are strongly encouraged.
why should you attend
As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems.
An understanding of this paradigm shift can be gained by comparing the compliance based Pharmaceutical GMP trainings with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach.
• Module 1 - Introduction to Quality and Compliance Concepts
• Module 2 - Differences between Medical Devices Companies and Pharmaceuticals
• Module 3 - Scope of the GMPs and the Quality Cycle
• Module 4 - Standards of Quality
• Module 5 - The Shifting Paradigm to Focus on Customer and User Satisfaction - The Quality Systems Approach
• Module 6 - A Comparison of Definitions and Terms
• Module 7 - Comparison of Personnel and Management Expectations
• Module 8 - Comparing Design Requirements
• Module 9 - Comparing Master Records
• Module 10 - Comparing Equipment Controls
• Module 11 - Comparing Material and Incoming Controls
• Module 12 - Comparing the Control of Processes
• Module 12 – Product Packaging and Labeling Comparisons
• Module 13 - Laboratory Quality Control and Device Evaluation
• Module 14 - Holding, Distribution, & Returns
• Module 15 - Problem Solving: Deviations, Complaints, and CAPA
• Module 16 - How about Part 11
• Module 18 - Current Trends
• Module 17 - Review and Wrap-up
• Scope of the GMPs and the Quality Cycle
• The Shifting Paradigm to Focus on Customer and User Satisfaction - The Quality Systems Approach
• Comparing Design Requirements
• Comparing the Control of Processes
• Product Packaging and Labeling Comparisons
• Laboratory Quality Control and Device Evaluation
WHO WILL BENEFIT
• Quality Control Professionals
• Regulatory Affairs Professionals
• Operations Departments
• Quality Assurance Managers
Howard Cooper has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward thinking quality leader.
Mr. Cooper built on this experience to set up a pharmaceutical /medical device and combination product quality system. Since that time, he has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.