$1,289 – $5,989

Robust Quality System Approach to Pharmaceutical Products: Scientific Basis...

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New Brunswick

New Brunswick, NJ

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Description

This course will provide an overview of some relevant rules and regulations concerning their scientific basis, development and interpretation. It will prepare the attendees in implementing such regulations, and associated guidance documents, in a scientific and logical manner.

Learning Objectives:

Appendix: Rules and regulations pertaining to quality of pharmaceutical products

This course will provide an overview of some relevant rules and regulations concerning their scientific basis, development and interpretation. It will prepare the attendees in implementing such regulations, and associated guidance documents, in a scientific and logical manner.

Seminar Instructor Dr. Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products.


Areas Covered:

  • Pharmaceutical Science
  • Pharmaceutics
  • Product Development
  • Analytical Chemistry
  • Method Development/Validation
  • Regulatory and Pharmacopeial Requirements
  • Manufacturing and Quality System Including cGMP & GLP
  • Compliance and ISO requirements
  • Quality Management System

Who will Benefit:

Anyone working as bench chemist/analyst, supervisor, manager, director or vice president in pharmaceutical manufacturing facilities, including laboratories and associated contract organizations, of innovator and generic companies for human and animal products, active and inactive (excipients) ingredient suppliers, contract research & development organizations, consultants and consulting organizations, suppliers of testing equipment in particular drug dissolution apparatuses in the following areas:

  • Pharmaceutical Development
  • Analytical methods (pharmacopeial, regulatory or in-house developed)
  • R & D Departments (both analytical and formulation)
  • Project Managers
  • Scientists/Analysts
  • Project Management
  • Quality Control
  • Quality Assurance
  • Regulatory Affairs
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

Topic Background:

Pharmaceutical product developments, manufacturing and assessments are heavily regulated by concerned national and international authorities. To attain marketing authorizations usually in each and every country or region manufacturers are required to meet specific regulations and standards which are further supported by various guidance documents. There exist huge and seemingly endless varieties of such regulations and standards, which make it extremely difficult to comprehend and apply these in an objective manner. Although all these regulations and standards are supposed to be based on scientific foundation, however, science aspect seemingly has been absent, in fact, in many case, it has been violated. By taking a “back to the basics” approach, this course will first describe the required fundamental scientific principles followed by description of most commonly required regulations and standards in a systematic way using US FDA’s regulations and standards as the base.


DAY 01(8:30 AM - 4:30 PM)


  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction: Interaction with attendees (1 Hour)
    • Expertise and experiences of attendees - their expectations from the course/training
    • My academic background, expertise and experiences working with the regulatory agency (Health Canada)
    • Philosophy of my teaching
    • Why am I teaching this course?
    • What will you gain from this course? - Uniqueness!
  • Science, science and science! (4 -5 Hours)
    • Why science and what kind of science is needed to understand such a training?
    • Who will use your science (supervisors, management, regulators and eventually consumer/patients)?
    • Fundamental principles and requirements of underlying science: An overview
      • Chemistry and analytical chemistry
      • Drugs/pharmaceuticals/medicines vs drug/pharmaceutical/medicinal products
      • Cosmetics, devices
      • Pharmacology, pharmaceutics, pharmacokinetics
      • Statistics, modelling
  • Manufacturing (1 Hour)
    • Manufacturing and its processes
    • cGMPs - current practices and issues, how to address these - input/output model.
    • Quality - defining it, measuring it and documenting it.
    • Compliance vs Quality

DAY 02(8:30 AM - 4:30 PM)


  • The Laws: Why and what (1/2 Hour)
  • Regulatory specifics: (4-5 Hours)
    • Regulations and guidance – US FDA
      • Good laboratory practice (21CFR Part 58)
      • Current good manufacturing practice (21CFR Parts 210/211)
      • Quality system regulation (21CFR Part 820)
    • Regulation and guidelines – Canadian & International
      • Corresponding Canadian Statutory Orders and Regulations (SOR/98-282);
      • Corresponding European Regulations (e.g. 93/42/EEC, 2007/47/EC)
      • Others (Depending availability of time e.g. ANVISA)
    • Regulation and guidelines – Putting it all together
    • International Organization for Standardization (e.g. ISO13485:2016)
    • ISO requirements vs GMP requirements.
    • Record keeping, validation and audits (21CFR Part 11)
    • Setting your “own” rules and standards!
  • Q & A, Discussion and Conclusions (1 Hour plus)


Saeed Qureshi

Saeed Qureshi
Principal, PharmacoMechanics

Dr. Saeed Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. His areas of expertise include: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.

Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.

Since 2015 Dr. Qureshi has been working as an independent consultant. A detailed description of his expertise and the services he provides may be obtained from the website (www.pharmacomechanics.com).


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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