Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar

By: Dr. Nanda Subbarao, Senior Consultant, Biologics Consulting Group
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Course “Key GMP Systems in Pharmaceutical and Biotech Labs” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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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:

Day One (8:30 AM - 5:30 PM)
8:30 AM - 9:00 AM: Registration Process
9:00 AM: Session Start Time
9:00 AM - 10:00 AM: Introduction and overview of the GMPs
10.00 AM-12:30 PM: Out of specification investigations including an interactive exercise
12:30 PM -1:30 PM: Lunch
1:30 PM - 3:30 PM: Lab operations and a review of relevant 483s in an interactive exercise
3:30 PM – 5:30 PM: Equipment program and a review of relevant 483s in an interactive exercise
Day Two (8:30 AM - 5:00 PM)
8.30 AM -12:00 PM: Stability and a review of relevant recent 483s in an interactive exercise
12:00 PM -1:00 PM: Lunch
1:00 PM – 5:00 PM: Method validation and a review of relevant recent 483s in an interactive exercise

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.

Location :
Courtyard Philadelphia Downtown
21 N. Juniper Street
Philadelphia, PA 19107
TEL: 215-496-3200
February 12-13, 2015

How to Reach

General Driving Directions:

Driving Directions from Philadelphia International Airport – PHL: 10 mile(s) SE
  • Take Interstate 95 North to Interstate 676 West
  • Exit at Broad Street (Route 611)
  • Stay in the left lane and take the first left turn onto Vine Street
  • Continue on Vine Street to 12th Street and turn right
  • Proceed to Market Street and turn right
  • Follow Market Street toward City Hall and the hotel will be on the right immediately after the first traffic light.

Other Transportation:

Bus Station
  • Greyhound Bus Lines: 0.3 mile(s) E

Subway Station
  • 13 St Station: 0.1 mile(s) SE
  • Blue Line: 0.1 mile(s) S

Train Station
  • Amtrak-PHL: 1.2 mile(s) W

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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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 from the start date of the event.

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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.

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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.

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Philadelphia, PA, 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.