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Robust Quality System Approach to Pharmaceutical Products: Scientific Basis and Implementation of Current Regulations  

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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

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Seminar Summary:

This course will provide an overview of some relevant rules and regulations concerning their scientific basis, development and interpretation. (see full course description)

 

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Training Course Syllabus:


Robust Quality System Approach to Pharmaceutical Products: Scientific Basis and Implementation of Current Regulations

Course 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.

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

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)

Seminar Summary:

This course will provide an overview of some relevant rules and regulations concerning their scientific basis, development and interpretation. (see full course description)

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