ComplianceOnline

This course is intended for employees who need a basic understanding of the FDA rules and regulations for pharmaceuticals. It will cover the basics of various ways to bring a product to market as well as Current Good Manufacturing Practice (cGMP). Items to be discussed include Over-the-Counter (OTC) Monographs, New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), product development overview, Investigational New Drugs (INDs), concepts in clinical trials and bioequivalence trials, amendments and supplements to applications, analytical method and process validation, cGMPs and FDA Inspections.

The course is not intended to prepare a student to create any of the matters discussed. Rather it is intended to give the student enough knowledge so that he or she can intelligently participate in discussions of strategy and assignment of resources.

Learning Objectives:

  • Understand the way FDA differentiates between OTC and Prescription pharmaceutical products
  • Understand the basics of OTC Monographs
  • Understand when an IND. NDA or ANDA is required
  • Describe the various stages of product development for Monograph, NDA and ANDA products
  • Understand the basic concepts of clinical trials
  • Understand the basic concepts of bioequivalence and pharmaceutical equivalence
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
  • Basic concepts of Electronic Common Technical Documents (eCTDs)
  • Understand application amendments and supplements
  • Understand the basic concepts of method validation and process validation
  • Describe the items listed under cGMPs
  • List the various types of FDA inspections
  • List the best way to respond to a 483 (Inspectional Observations)
    ….much, much more

Areas Covered in the Webinar:

  • Over-the-Counter (OTC) Monographs
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Product Development Overview
  • Concepts in Clinical Trials and Bioequivalence Trials
  • Amendments and Supplements to Applications
  • Analytical Method and Process Validation
  • cGMPs and FDA Inspections

Who will Benefit:

  • Regulatory Affair
  • Quality Assurance
  • Quality Control
  • Compliance
  • Manufacturing
  • Scientist
  • R&D
  • Engineer
  • Product Development
  • Risk
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 9:00 -10:00
    • Seminar objectives review, expectations and scope.
    • What is the FDA?
    • What laws does the FDA enforce?
  • 10:00 -11:00
    • OTC and Prescription Products
      • What’s the difference?
      • What’s a Monograph?
      • NDA/ANDA OTCs and switches
    • Introduction to Product Development
      • Stages
      • Safety in IND and NDA
      • INDs
      • Safety studies, bioavailability, clinical trials and bioequivalence
      • Labeling and Indications for Use
    • Questions and Discussion
  • 11:00 -12:00
    • Applications
      • eCTDs
    • Amendments and Supplements
    • Questions and Discussion
  • 12:00 -1:00: Lunch
  • 1:00 -2:00
    • more discussion of Applications
    • Introduction to cGMPs
      • Sections of the Regulation
      • Validation of Methods and Process
    • Questions and Discussion
  • 2:000 -3:00: more discussions of CGMPs
  • 3:00 -5:00: General discussions as needed. There will probably be many things that require clarification.
Day 02(8:30 AM - 12:00 PM)
  • 8:30 -9:00: Registration & Meet & Greet.
  • 9:00 -10:00
    • Review Seminar objectives review, expectations and scope.
    • FDA Inspections
      • Types of FDA Inspections
      • Pre-informed or not
      • What to expect
  • 10:00 -12:00
    • 483s and Warning Letters
      • What’s the difference?
      • Responding to FDA
    • Damage Control
    • Questions and Discussion
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Loren Gelber

Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

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ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
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 @ customercare@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 $300 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 ($300) 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.

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
Platinum Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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