WHO Good Practices for Pharmaceutical Quality Control Laboratories
Live, Interactive Training Webinar
Available Live On-Demnad
Instructor: Kim Huynh-Ba Biography>>>
Available Live On-Demnad
The Quality Control (QC) laboratory plays a critical role in the entire development process. The laboratory must have critical functions and robust quality systems necessary to ensure that the product meeting established specifications and procedures satisfy regulatory requirements.
This live training webinar will cover Management and Infrastructure, Materials, Equipment and devices, Working Procedures and documentation and Laboratory Inspection.
- Understanding the role and importance of the Quality Control (QC) laboratories. - What a QC laboratory needs to be successful supporting the production. - Ensure the appropriate level of communication and coordination between the staff involved in the testing. - Establish and maintain a quality management system appropriate to the scope of its activities. - Ensure that policies and procedures are adequate to assure the quality of test results that it generates. - Establish documentation system to ensure accuracy and compliance with current standards.
Webinar outline and time breakdown:Time*
|9:15 AM||Log In Period|
|9:40 AM||Understanding the role and importance of the Quality Control (QC) laboratories,|
|What a QC laboratory needs to be successful supporting the production,|
|Ensure the appropriate level of communication and coordination between the staff involved in the testing,|
|10:40 AM||Establish and maintain a quality management system appropriate to the scope of its activities,|
|Execute the validation protocol,|
|Ensure that policies and procedures are adequate to assure the quality of test results that it generates,|
|Establish documentation system to ensure accuracy and compliance with current standards,|
|11:30 AM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance Personnel
- Quality Control Personnel
- Auditor Professionals
Instructor: Kim Huynh-Ba
Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.
She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>
All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.
Live Training Benefits:
Live Training Benefits:
• Pharma Webinars training webinars and programs are presented exclusively as live events only.
• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.
• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.
• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.
• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.
• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.
• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.
• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.
• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.