Course Description:
This workshop will provide the audience with an overview of the key systems which have been mentioned by FDA inspectors as major areas of concern in FDA regulated pharma laboratories. The topics addressed will include FDA requirements for OOS investigations, equipment program, pharmaceutical and biologics stability programs, method validation and handling regulatory inspections. During the discussion of each of the areas listed below, the workshop participants will work through a series of related FDA 483s to fully understand FDA expectations and the errors which lead to the 483s.
FDA requirements for the equipment program
- Equipment qualification
- Equipment operation and maintenance
FDA requirements for pharmaceutical and biologics stability programs
- Overview of ICH and WHO requirements for stability programs
- What are the stability study requirements for Phase I, Phase II and Phase III clinical studies
- Stability methods and specifications
- 483s related to stability programs and lessons learned
FDA requirements for method validation
- Overview of relevant ICH guidances and USP chapters
- What are the requirements for different methods
- 483s related to method validation and lessons learned
Regulatory inspections
- How to prepare for regulatory inspections
- How to handle regulatory inspections
Early registrations will receive a CD with relevant regulatory and guidance documents.
Who Will Benefit:
- QC chemists, supervisors and managers
- R&D chemists, supervisors and managers
- QA managers and personnel
- Regulatory affairs personnel
Course Outline:
|
Meet Your Instructor
 |
Dr. Nanda Subbarao Senior Consultant, Biologics Consulting Group Dr. Nanda Subbarao is currently a senior consultant with the Biologics Consulting Group specializing in analytical, stability, CMC and GLP/GMP quality systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and commercial phases. Her hands-on expertise also covers setup of cGMP/GLP complaint quality systems for laboratory and stability programs as well as upgrade of existing quality systems for products during development and commercial phases. She serves on the American Association of Pharmaceutical Sciences, Stability Focus Team Steering Committee. |
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
Testimonial
Feedback from some of our satisfied customers who have attended trainings and continue to use ComplianceOnline resources for their daily GRC needs.
The Key GMP Systems in Pharmaceutical and Biotech Labs seminar was very good. The presenter, Nanda, was knowledgeable and brought up some interesting challenges faced when dealing with OOS, stability and method validation activities. I felt the entire seminar was relevant to my job, which is a rarity. I plan on using the material and ideas from the seminar to evaluate some of the approaches we are currently taking. I felt I could have used a little more time listening/ talking with the presenter. I was also impressed that Nanda responded quickly to a question I had after the seminar via e-mail.
- QA Specialist, Stiefel, a GSK company
Nanda’s In-person Seminar on Key GMP Systems was one of the best seminars I attended. Many a time, we look at work place as the best place to work and we ignore the minor and major improvements that could be done in the facility. After attending the seminar I look at my work place as an auditor and I definitely see the potential improvement areas. In future I would like to attend more seminars with ComplianceOnline.
- QA/QC Supervisor, Xttrium Laboratories, Inc.
I found the GMP laboratory systems seminar to be very informative and educational. Dr. Subbarao provided expert guidance on key industry topics and practical advice on ways to maintain compliance. She was engaging and a very effective speaker. I would recommend this class with Dr. Subbarao.
- Vice President - Regulatory Affairs/Quality, Inhibitex Inc.
|
Local Attractions
Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.
Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.
Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.
The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.
National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”
The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.
The Barnes Foundation
The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.
The Rocky Statue
One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.
Franklin Square
Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.
