Understanding & Implementing Quality Systems for the Pharmaceutical Industry

Course 0725 - 2 Days - 1.4 CEUs

$1095 USD
$985 USD with 30-Day Prepay Savings
$547 USD for Third Attendee
$492 USD for Third Attendee with 30-Day Prepay Savings
Save 10% to 30% in our Customer Rewards Program


The Pharmaceutical Industry is challenged with bringing new products to market in a timely and risk managed fashion. In addition, the production of drugs needs to be controlled and needs to assure that all products meet specifications for safety, identity, strength, quality, and purity. Regulations, current Good Manufacturing Practices (cGMP), in accordance with 21CFR210 and 211 help companies implement quality practices to achieve those production requirements. The challenge is to implement quality practices that don’t inhibit the company but rather assist it in achieving the goals both in new product development and manufacturing/production.

This course will teach the current regulations for drug manufacturers, cGMP, 21CFR210/211, and the current thinking of the FDA on how the drug industry should manage quality. This includes how the FDA will be looking at a ‘risk based’ approach to regulating the drug industry. The course will also show how to implement and maintain a ‘quality system’ that will help the company manage risks and introduce and maintain quality drug products in the market place.


Key Session Topics

• Why does the FDA regulate Drugs?
• Current Good Manufacturing Practices (cGMP) per 21CFR210 and 211
• Current thinking of FDA for a 21st Century approach to the Drug Industry
• Quality and New Product Development
• Implementing a Systems Based approach
• Benefits of Quality Management Systems for Drug Manufacturers

Dates, Locations, and Registration  

How to Register

You can register for a course in either of two easy ways:

• Call us at (800)374-3818.
• Click on a date in the table below and complete the online registration form.

Register online or call 800-374-3818.

7/31/2008 - 8/1/2008 Princeton, NJ Call us for hotel information

12/4/2008 - 12/5/2008 Princeton, NJ Call us for hotel information

If you have questions about this course, submit a Course Information Request or call us at 1-800-374-3818. To learn about the savings and instructional benefits of training five or more participants at your location, submit an On-Site Quote Request or call us at 1-800-374-3818. To learn how you can save 10% - 30% on course registrations with SAI Global as your preferred training provider, submit a Customer Rewards Request or call us at 1-800-374-3818.

Who Should Attend

• Quality and Manufacturing personnel new to drug manufacturing
• Internal auditors
• Regulatory Affairs and Quality assurance professionals needing refresher and update training
• Management personnel looking for answers to quality problems or quality constraints

Prerequisites
There are no prerequisites for this course.


What's Included in the Price
The course price includes:

• breakfast, lunch, and refreshments each course day -- special dietary needs are no problem
• a student manual developed by experienced instructional designers
• a copy of the standard (where applicable)
• forms, templates, and worksheets for use back at the workplace (for auditing and other applicable courses)
• certificates upon completion of course requirements

Hotels:
Although hotel reservations and accommodations are not included in the course price, we do secure discounted room rates for most of our courses.

Training at Your Location:
Please contact us at 1-800-374-3818 for information about on-site pricing.


Support from Registration through Certificate of Completion
At every step of the public course process, the SAI Global Customer Relations team is singularly committed to providing an unparalleled level of support so you can focus on the learning event instead of on preparations and logistics.

1. Once you register for a course by phone, by fax, or online, we send you a registration confirmation e-mail.
2. Approximately 3 weeks prior to the course, or if you register closer to the start date, we mail and/or e-mail you precourse materials, if applicable.
3. If any changes to course/hotel location occur, we contact you immediately.
4. Approximately 2 weeks prior to the course start date, we e-mail you a course reminder to confirm your attendance.
5. For the course itself, we provide everything you need to facilitate your learning experience.
6. At the conclusion of the course, the instructor submits test scores (where applicable) and other necessary paperwork to the home office for processing.
7. You receive a certificate of completion and confirmation of continuing education units (CEUs) earned.