ComplianceOnline

Course Description:

Course "FDA Compliant GLP for Nonclinical Studies - For Pharmaceutical and Medical Device Industries" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

Understanding GLP regulations and requirement and achieving GLP compliance can significantly expedite the regulatory processes, bringing innovative medical products to the market faster and saving enormous amount of your unnecessary time, efforts and investment.

During this interactive workshop, Dr. David Lim (Regulatory Doctor) will walk you through the relevant and applicable US regulations, regulatory requirements and guidance necessary for good laboratory practice (GLP) and GLP compliance. This workshop is intended to provide guidance on GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for pharmaceutical and medical device products for human use regulated by the United States Food and Drug Administration (US FDA). During this workshop (2nd day), group discussions on implementing GLPs will be engaged.



Areas Covered:

The following areas will be discussed during this workshop:

  • US FDA GLP regulations and requirements
  • Good laboratory practices: scope, objectives and definitions
  • Organization and personnel: personnel, management, study director and quality assurance unit
  • Facilities and equipment
  • Testing facilities operation: standard operating procedures (SOPs)
  • Test and control articles
  • Protocol and conduct of a GLP study
  • Records and reports
  • Implementing GLPs
  • Preparing for GLP inspection
  • Numerous case studies for deficiencies and for improvement
  • GLP workshop for GLP implementation


Who will Benefit:

This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, handling nonclinical laboratory data and documents concerning animal and human drugs, biologics, biosimilars, medical devices or any combination products thereof.  It is particularly useful for those who are engaged in conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for FDA-regulated medical products.  This workshop is a must for those who are directly or indirectly involved in nonclinical laboratory studies regulated by the FDA.

The employees who will benefit include:

  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Regulatory affairs (associates, specialists, managers, and directors)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Site managers, and consultants
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors




Areas Covered/Agenda :

Schedule for Day 1, 9:00 AM - 4:00 PM | (GLP Seminar)
Morning  
9:00 AM - 10:30 AM
  • US FDA GLP regulations and requirements
  • Good laboratory practices: scope, objectives and definitions
  • Organization and personnel: personnel, management, study director and quality assurance unit
10:30 AM - 10:40 AM Short Break
10:40 AM - 12:00 Noon
  • Facilities and equipment
  • Testing facilities operation: standard operating procedures (SOPs)
  • Test and control articles
12:00 Noon - 1:00 PM Lunch
Afternoon  
1:00 PM - 2:30 PM
  • Protocol and conduct of a GLP study
  • Records and reports
  • Implementing GLPs
2:30 PM - 2:40 PM Short Break
2:40 PM - 4:00 PM
  • Preparing for GLP inspection
  • Numerous case studies for deficiencies and for improvement
Schedule for Day 2, 8:00 AM - 12 Noon | (GLP Workshop)
Morning  
8:00 AM - 9:30 AM
  • Agenda for group discussion
  • Intra-group discussion
  • GLP implementation and checklist
09:30 AM - 09:40 AM Short Break
09:40 AM - 12:00 Noon
  • Inter-group presentation
  • Speaker moderation and discussion





Meet Your Instructor

Dr. David Lim
Ph.D., RAC, ASQ-CAQ

Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.





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Call +1-650-284-1699 for more details.
or email to p.shetty@complianceonline.com

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Payment Mode

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Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

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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 @ editor@complianceonline.com

Payment:
Payment is required before 2 days of 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 $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($150) 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 before 5 working days from 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 use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Testimonials

I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.
- QC, Regulatory affair

My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.
- Regulatory Manager

I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.
- Regulatory Manager

I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.
- Quality Analyst

Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.
- QC, Regulatory Affairs

All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. David Lim is an excellent friendly presenter. Overall it was good value for the price with ComplianceOnline.
- Managing Director

ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.
- Manufacturing Engineer

Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!
- Attorney (Patent)






Accreditation




The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.



After completion of course "FDA Compliant GLP for Nonclinical Studies - For Pharmaceutical and Medical Device Industries" RAPS certificate will be issued to attendee.






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