Manufacturing and Development of APIs

  • PART 1: April 7, 2021
    1:00 pm - 3:30 pm
  • PART 2: April 14, 2021
    1:00 pm - 3:30 pm


Ontario, Canada

Certification Areas

Course Objective

Producing life-saving medicines for patients is a constant and challenging task.  Companies, regulatory bodies, and patients are all concerned with speed to market, and effective, safe drug products. The webinar will provide an overview of how to critically evaluate the manufacturing and development of APIs to ensure safe, efficacious, and high-quality products are delivered to patients.



Course Outline

PART 1: Manufacturing of APIs 

  1. Evaluation of the entire manufacturing process starting with raw materials to the final product
  2. Critical process step identification
  3. Business practices, SOPs, electronic forms, and training associated with the manufacturing process
  4. API Manufacturing
    • * Catalysis
    • * Flow Chemistry (continuous processing)
  5. Extractables and Leachables (E&L) evaluation across the manufacturing process, container closure (CCS), and analytical testing of E&L
  6. Harmful impurities – i.e., Nitrosamine
  7. Cleaning Validation – health-based exposure limits and toxicological evaluations
    • * Worst Case Residue
    • * Hold Times (Clean, Dirty, and Sterile Stand)
    • * Campaign Changeover Strategy
    • * Toxicological Assessment

PART 2: Drug Development of APIs

  1. Drug metabolism and pharmacokinetics
  2. Molecule Characterization
  3. Solubility
  4. Dosage
  5. Formulation and patient compliance



The course materials and access link will be sent to all registrants closer to the webinar date.



Who Should Attend?

The webinar is applicable to all personnel working within the Pharmaceutical/Biotechnology industries, especially involved in quality, manufacturing, research and development, regulatory affairs, product testing, engineering, and environmental health, and safety.



Course Leader: Dr. Wendy Haines

Dr. Wendy Haines is the Associate Director of Technical and Scientific Services at PharmEng Technology and has over 20 years of toxicology experience in both the research and biopharmaceutical arenas, encompassing process design, analysis, validation, project/protocol management, and scientific writing.  She has BS Degrees in Pharmaceutical Sciences & Biology from Campbell University, a Ph.D. in Toxicology from the University of North Carolina, Chapel Hill and is a board-certified toxicologist (Diplomate of the American Board of Toxicology, DABT) and a Certified Quality Auditor (ASQ CQA). Dr. Haines has impacted human health laws at Environmental Protection Agency (EPA) starting in 1997, worked on the Genome Project between EPA and National Institute of Health (NIH), and later conducted her Ph.D. at EPA performing directed research for the Office of Pesticides of EPA.  Wendy was a study director and acted as a single point of contact for all aspects of a study; oversaw both in vivo and in vitro experimental studies for both commercial clients and the National Toxicology Program (NTP). Wendy moved from a contract laboratory setting to a consultant company providing toxicology, project management, and validation services to pharmaceutical and biotechnology manufacturers.  Dr. Haines has conducted close to 250 product toxicology safety assessments [for manufacturing determinations (SUT vs. stainless) and worker safety evaluations) for contract manufacturers and provides guidance on extractable and leachable projects, product testing, and worker safety programs.

Registration Deadline: 2 Apr 2021

Student Ticket: $100.00 Sold Out
Basic Ticket: $360.00 Sold Out
Pro / Pro Plus Ticket: $310.00 Sold Out