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

 
  August 27, 2014  
     
 


Compliance Trainings, Online
2014-09-12


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:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

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, 
Canada 
Customer Support : #416-915-4458 
Email : 
support@compliancetrainings.com

 
 
Organized by: Compliance Trainings
Invited Speakers:

Heath Rushing is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications, and long-term training plans in quality and statistics across a variety of industries to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences.

 
Deadline for Abstracts: 2014-09-12
 
Registration:

https://compliancetrainings.com/siteengine/Login.aspx

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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