Webinar on Quality by Design (QbD) Across the Product Lifecycle

This webinar will demonstrate how to integrate those QbD principles into a pharmaceutical quality system.

12 Sep 2014 at Online

Pharmaceuticals/Drug Discovery, Biotechnology

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As stated in Q8, the ICH guidance document on pharmaceutical development, drug product should meet its intended product performance as well as meet the needs of patients. Although the strategy for pharmaceutical development may vary from company-to-company and/or from product-to-product, a systematic approach defined by quality by design (QbD) principles is encouraged.
Further guidance and policies have been provided to explain how the QbD approach should be integrated into the pharmaceutical quality system including process design, qualification, continued process verification, risk management, and validation. Although guidance on implementation of these requirements is prevalent, many companies have not yet implemented QbD into their quality systems; regulatory agencies have made it clear this will change. In fact, the chemistry, manufacturing, and controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) recently released a manual on policies and procedures (MAPP) explaining how reviewers will begin to enforce the requirements from these guidance documents. The Director of the Center for Drug Evaluation and Research (CDER) at the FDA recently (May 2014) co-authored a paper in The American Association of Pharmaceutical Scientists detailing the concept and reiterating the importance of using a QbD approach to pharmaceutical development. This webinar will demonstrate how to integrate those QbD principles into a pharmaceutical quality system.
Areas Covered in the Session :
Quality by Design
Setting specifications
Measurement systems analysis (MSA)
Determining critical quality attributes (CQAs) and process input parameters
Process development using design of experiments (DOE)
Control or risk management plan
Process validation
Commercial manufacturing
Who Will Benefit:
This webinar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design, validation, or manufacturing/control including:
Process Scientist
Process Engineers
Design Engineers
Product Development Engineers
Regulatory Professionals
Compliance Professionals
Design Controls Engineers
Six Sigma Green Belt
Six Sigma Black Belt
Continuous Improvement Managers
Price Tags:
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct,
Mississauga, ON L5V 2V5,
Customer Support : #416-915-4458
Email : support@compliancetrainings.com