Symmetric
  • TRAINING COURSES
  • IN-HOUSE TRAINING
  • CLIENTS
  • TRAINERS
  • BLOG
  • ABOUT US
  • CONTACT

Join Symmetric Newsletter

Sign up today so you don't miss any special offers, new events and pharma breaking news.

TOP 3 Pharma & Biotech Worldwide News Once a Month

Interviews With Industry Professionals Once Every Three Months

Regular Event Calendar & Special Offers Once Every Six Months

Symmetric s.r.o.

Mliekarenska 7

82109 Bratislava

Slovak Republic

ID: 47 068 124

VAT No: SK2023741973

Office: +421 948 262 346

LinkedIn

Booking & Support

Phone (EU):+421 948 262 346 (9:00 - 17:00 CET)

Phone (US):+1 857 392 2714 (9:00 - 16:00 ET)

Email:info@symmetric.events

A real member of our team answers our chat

Terms & ConditionsPrivacy PolicyChange Your Cookie Consent

© 2026 Symmetric s.r.o.

Specifications for Small Molecule Drug Products
Pharma & Biotech

Specifications for Small Molecule Drug Products

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Current regulatory expectations

Current regulatory expectations

Learning Objective

How to set meaningful specifications for raw materials and drug products

How to set meaningful specifications for raw materials and drug products

Learning Objective

Using the principles of quality risk management for impurity control

Using the principles of quality risk management for impurity control

Learning Objective

Avoiding common errors and omissions

Avoiding common errors and omissions



KEY TOPICS

Regulatory guidance Specifications (ICH Q6A) Impurities (ICH Q3 family of guidance documents) Genotoxic impurities (ICH M7)
Specifications (ICH Q6A)
Impurities (ICH Q3 family of guidance documents)
Genotoxic impurities (ICH M7)
Risk assessments for residual solvents, elemental impurities and extractables
Excipient specifications
Control of drug substance vs. drug product
In-process specifications and parametric release
Release vs. shelf life specifications
Specifications for specific dosage form types Oral liquids/solids Parenteral drug products Topical drug products Inhalation drug products Liposomes
Oral liquids/solids
Parenteral drug products
Topical drug products
Inhalation drug products
Liposomes
Justifying new impurities in generic drug products
Test method suitability
A risk-based approach to the control of genotoxic impurities

TRAINER

Dr Mark Powell

Dr Mark Powell

Mark Powell Scientific Limited, UK, Director

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, and stability/stress studies.

Learn More →