Course Catalog

Quality Control of Small Molecule Drugs and Biologics: Fundamentals and Best Practices

This introductory course provides an overview of key drug quality concepts, standards and practices for the pharmaceutical and biotechnology industries. A recent incidence of adulterated Heparin and a major recall of childrens medicines are used to demonstrate the difficult challenges of maintaining drug quality in a global supply chain.

Interactive lectures explore quality systems, control processes and regulations in clinical development and drug manufacturing. You will learn the roles of quality assurance (QA), quality control (QC), and the chemistry, manufacturing, and control (CMC) drug development process in ensuring the safety, efficacy and quality of drug products. The analytical chemistry methodologies used in quality assessment are surveyed. The course addresses Quality by Design (QbD), Critical Quality Attributes (CQA), Risk Assessment/Management, and Process Analytical Technologies (PAT). It also covers industry-standard processes such as change control, SOPs, qualification/validation, release testing, specifications, and deviations. Specific quality attributes of large-molecule recombinant biological products are described and contrasted with the quality attributes of small molecule organic drugs.

Course Details

Information

This introductory course provides an overview of key drug quality concepts, standards and practices for the pharmaceutical and biotechnology industries. A recent incidence of adulterated Heparin and a major recall of childrens medicines are used to demonstrate the difficult challenges of maintaining drug quality in a global supply chain.

Interactive lectures explore quality systems, control processes and regulations in clinical development and drug manufacturing. You will learn the roles of quality assurance (QA), quality control (QC), and the chemistry, manufacturing, and control (CMC) drug development process in ensuring the safety, efficacy and quality of drug products. The analytical chemistry methodologies used in quality assessment are surveyed. The course addresses Quality by Design (QbD), Critical Quality Attributes (CQA), Risk Assessment/Management, and Process Analytical Technologies (PAT). It also covers industry-standard processes such as change control, SOPs, qualification/validation, release testing, specifications, and deviations. Specific quality attributes of large-molecule recombinant biological products are described and contrasted with the quality attributes of small molecule organic drugs.

Who Should Attend

This course is beneficial for scientists and non-scientists working in range of disciplines across the pharmaceutical industry who want to improve their understanding of CMC, quality systems, analytical chemistry and quality control processes in the industry. This course is also useful for non-pharma scientists seeking a technical overview of the challenges and opportunities for drug development and quality management (QA, QC, regulatory, supply chain / project management) in pharma related industries (pharmaceutical, biotechnology, generics, over-the-counter and nutraceutical industries).

Agenda

  • Introduction to Drug Quality
    • Class introduction, goals and take-away messages, administration, grading, homework and discussion questions.
    • What is drug quality? Common quality issues of drug products
    • Important quality attributes: Appearance, form, identity, potency, purity, chirality, uniformity, bioavailability, stability, microbial activity, sterility&
    • Case studies (Heparin, McNeil and Acino recalls)
    • A brief overview of drug discovery / development process and CMC.
    • Quality issues and nuances in nutraceutical and other related industries.
  • Quality Assurance through CMC Drug Development Process
    • The CMC (Chemistry, Manufacturing and Control) Process
    • Scientific investigation, preclinical demonstration of safety and efficacy, API process scale-up, formulation, analytical development, registration requirements (IND, NDA), manufacturing process development and validation, quality control, pre-approval inspections.
  • Regulations, quality standards and systems
    • GLP, GMP, GCP, ICH guidelines, ISO 9000 and other public standards
    • Regulatory oversight, registration, marketing approval, audits, inspections, pharmacovigilance complaints, warning letters, consent decrees, and recalls, &
    • Internal quality systems and processes, SOPs, equipment, facility, personnel, signatory and approval of control documents, data integrity and audit trail, materials control, manufacturing, packaging, labeling, transportation, storage and dispensing&
    • Setting relevant specifications, sampling, sample chain of custody, developing relevant testing methods, method validation, reference standard qualification, release testing, documentation, review and QA product release.
    • Functions and responsibilities of an independent QC / QA unit.
  • Modern Quality Concepts
    • ICH Q8, Q10, Quality by Design (QbD), Critical Quality Attributes (CQA), Design of Experiment (DOE) to explore design space, Process Analytical Technologies (PAT), at line, online or inline in process control (IPC), risk-based quality management ICH Q9.
  • A survey of analytical Chemistry techniques and quality control methodologies
    • Chromatography (HPLC, GC, and IC)
    • Spectroscopy (IR, UV, MS, NMR, NIR, Raman, ICP/AES, XRPD)
    • Chemical (wet chemistry, solubility, pH, titration, KF, ROI)
    • Compendial methods (USP and EP)
    • Others (CE DSC/TGA, microscopy, ICP/AES, DVS, particle size distribution, biological/micro testing)
  • QC of Small Molecule drug substance and product: specifications, release testing, COA, impurities and stability
    • A case study of a small molecule drug: specifications, release testing and COA
    • Anatomy of an analytical method and system suitability testing
    • API: physical, appearance, solid state properties, form, chemical (id, MW, structure, purity, chiral purity, potency), moisture, heavy metals, ROI, residual solvents, solubility&
    • Drug products: physical, chemical, performance (dissolution), uniformity, microtesting &
    • Stability indicating method, forced degradation study, impurity characterization and qualification, specifications, chiral purity, genotoxic impurities
    • Stability: protocol, time points, long term and accelerated storage conditions, stability reports, and shelf life determination.
  • Critical quality attributes for recombinant biological products
    • Approaches to characterize heterogeneity of the active ingredient and define the critical quality attributes
    • Analysis of intact proteins (HPLC- IEC, RPLC, GFC, electrophoresis, CE, MS, pI, aggregates)
    • Analysis of fragments (LC/MS of peptide mapping, amino acid sequence)
    • Analysis of glycans, disulfide bridges (LC/MS) and other post-translational modifications
    • High order structures and biophysical analysis of proteins (CD and DSC)
    • Biological testing (binding assay, functional bioassay)

Course Locations

Date

TBA

Check-in opens at 7:30 a.m.

Course runs from 8:30 a.m. to 5:00 p.m.

Register Via Mail

Venue

The course fee includes a course binder and a continental breakfast.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.


Pricing
  Member Non-Member
Advanced $895 $1,095
Standard $1,095 $1,295

About the Instructor

  • Michael W. Dong

    is a principal in MWD Consulting. He was formerly Senior Scientist at Genentech, Research Fellow at Purdue Pharma, and Staff Scientist at Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from City University of New York and has 100+ publications and 3 books.