|
Live Webinar Understanding and Implementing a Quality by Design Progra
Everyday
10.00 AM
http://https://worldcomplianceseminars.com/webinardetails/345
Hollywood
FL Wisconsin 33021
Report Abuse
|
|
Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application.
Why should you attend :
The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use.” Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.
Areas Covered
• Quality Target Product Profile (QTPP)
• Risk Assessment
• Using Models
• Design of Experiments
• Developing a Design Space
• Process Analytical Technology (PAT)
• FMEA and Control Plan
• Target Operational Profile
• Control Strategy
Who will Benefit
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:
• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Process owners
• Quality engineers
• Quality auditors
• Development professionals
• Senior development managers
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Steven Laurenz– Chemical Engineering M.S. – Michigan State University
Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.
Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortiums.
Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics
|$179 One Dial-in One Attendee|$279 One Dial In - Max 10 attendees|$695 Multiple locations upto 5 dial in|$249 Available within 24 hrs after|$299 CD/DVD will be dispatched after
https://worldcomplianceseminars.com/webinardetails/345
|
Phone: 03472825400
Email: subscribe (at) worldcomplianceseminars.com |
|
|
| Report Abuse |
|
|
| |
| |
|
| List your Event |
| | Similar Events | FL: Live Webinar Understanding and Implementing a Quality by Design Progra
Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile,
Date Posted: 26-Apr-18
| FL: Live Webinar Understanding and Implementing a Quality by Design Progra
Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile,
Date Posted: 26-Apr-18
| FL: Live Webinar Corrective and Preventive Action (CAPA) - Principles of L
Live Webinar Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
Description
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements a
Date Posted: 08-May-18
| FL: Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485
Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485
Description
The FDA CGMPs (21 CFR 820.30) and ISO QMS’ (ISO 13485:2016 7.3) expect companies to perform meaningful, results driven Design Control act
Date Posted: 27-Apr-18
| FL: Live Webinar Use / Human Factors Engineering to Satisfy the New IEC 62
Live Webinar Use / Human Factors Engineering to Satisfy the New IEC 62366-1, -2
Description
IEC has released a new medical device usability standard, IEC 62366-1:2015 -- Part 1: “Application of the new Usability Engineering Standard to Medic
Date Posted: 30-Apr-18
| FL: Live Webinar New and Expected Guidances on Data Standards and Electron
Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
Description
Each FDA center has different guidelines and processes to follow in order to have a successful submission for the re
Date Posted: 30-Apr-18
| FL: Live Webinar New and Expected Guidances on Data Standards and Electron
Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
Description
Each FDA center has different guidelines and processes to follow in order to have a successful submission for the re
Date Posted: 11-May-18
| Houston: Introduction to Risk Management: Medical Devices
DESCRIPTION
This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing p
Date Posted: 18-Apr-16
| FL: Live Webinar The prevention of human error in pharmaceutical manufactu
Live Webinar The prevention of human error in pharmaceutical manufacturing
Description
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to
Date Posted: 02-May-18
| FL: Live Webinar The prevention of human error in pharmaceutical manufactu
Live Webinar The prevention of human error in pharmaceutical manufacturing
Description
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to
Date Posted: 02-May-18
| Houston: Proper CAPA Management by Danielle DeLucy
DESCRIPTION
In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal
Date Posted: 18-Apr-16
| FL: Conducting a life sciences documentation and training gap analysis
Conducting a life sciences documentation and training gap analysis
Description
The relationship between government regulations, actual job tasks performed by workers, compliance requirements, equipment maintenance and
Date Posted: 27-Apr-18
| FL: Conducting a life sciences documentation and training gap analysis
Conducting a life sciences documentation and training gap analysis
Description
The relationship between government regulations, actual job tasks performed by workers, compliance requirements, equipment maintenance and operational requirements,
Date Posted: 29-May-18
| FL: Live Webinar FDA Compliance and Mobile Applications
Description
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, tobacc
Date Posted: 26-Apr-18
| Houston: Implementing a Change Control Quality System Successfully
DESCRIPTION
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking s
Date Posted: 15-Apr-16
|
|
Map locations are shown as per geocoding services and they depeneds on the accuracy of the address. If address is wrong it may show wrong map. If you put a listing which shows wrong map, please remove the listing and create a new one with correct address details.
Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks.
|
| Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks.
|
|
