ComplianceOnline
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.

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.





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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 @ editor@complianceonline.com

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:
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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.




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  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.







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