| |
|
|
|
CfPA - The Center for Professional Advancement, East Brunswick, NJ
January 30-31, 2013
Who Should Attend
This intensive course will benefit those who need to understand the responsibilities and functions of the Quality Unit in a pharmaceutical firm and how quality can be assured and controlled in the production of pharmaceuticals and related products. The material is particularly suitable for chemists, pharmacists, engineers and administrators working in the following areas:
• Research &Development
• Process Development
• Analytical Development
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Plant Operations
• Purchasing
• Engineering/Maintenance
• Corporate/Plant Management
The course will also benefit personnel in Regulatory Agencies and suppliers to the industry. Description
This course provides the basic principles and practices of quality assurance and control as functions and departments in the pharmaceutical industry. The material also applies to the biopharmaceutical, diagnostic, device and cosmetic industries and to suppliers, including API manufacturers. The discussions include the role of quality and the major elements of pharmaceutical quality, the impact of management practices, the features of an effective quality organization, quality management throughout the product life cycle – including GMPs compliance, and the role of corporate quality. The course discusses current quality issues including company reorganizations, outsourcing, the evolution of FDA approaches, global standards by such organizations as ICH and IPEC and the use of such techniques as risk management, QbD and the Quality System approach. Throughout, an emphasis is placed on the need to achieve quality at optimum cost. The course includes an interactive question/answer session.
|
|
|
|
|
|
|
|
Organized by:
|
|
CfPA - The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
Dr. Jerry Lanese; Pharmaceutical Quality & Technology Consultant
Dr. Jerry Lanese, an International Pharmaceutical Industry Consultant, has a Ph.D. in Analytical Chemistry from the University of Michigan. He began his career teaching Analytical Chemistry at the college level. He moved to industry where he has gained more than 30 years of quality control, quality assurance and analytical research experience in the pharmaceutical industry. He has worked in large and small pharmaceutical firms managing Analytical Research & Development and QA & QC functions. Dr. Lanese was the quality representative on the team that started manufacturing operations in Puerto Rico for a major pharmaceutical firm. For the past 17 years, he has been a consultant in the drug and medical device industries focusing on laboratory activities, performing quality assessments and helping both small and large firms to achieve a higher level of compliance. Dr. Lanese has been part of several teams working with firms under consent decree. Dr. Lanese is a member of the ASQ, and the Editorial Advisory Boards of and Journal of GXP Compliance.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
sberg@cfpa.com
|
|
|
|
|
|
|
|
|