Smithers Essentials: Extractables and Leachables Fundamentals

Upcoming course dates

Oct 17 2018 - Oct 18 2017 - $1,099.00

Select dates & register Enquire

Course Duration 2 days 

Cleveland, Ohio 

Overview

With a focus on patient safety, Smithers Rapra experts will provide you with the knowledge you need to comply with E&L requirements of regulatory agencies.

Learn the basic facts about extractables and leachables and what is required of a successful E&L study and why these studies are critical to the safety of the patient and the integrity of the pharmaceutical product.  

Standard Rate: $1,099 

Please contact Ryan Davidson at Rdavidson@smithers.com  for questions or more information. 

While there are no specific regulatory requirements for E&L, there are established organizations, working groups, and industry experts that provide guidance to the industry to ensure compliance with regulatory expectations in the various jurisdictions (US, EU, Asia Pacific, etc.)

By attending this year's E&L Fundamentals training, you will:

  • Gain a strong foundation in the field of E&L
  • Learn about important regulatory concerns
  • Find out how to comply with current regulatory expectations

What else will you learn from E&L Fundamentals? 

  1. Definitions of extractables and leachables and why they are important
  2. Overview of available sources for guidance on E&L including specific documents and industry groups
  3. Overview of the multitude of factors involved in E&L study design
  4. Get regulatory guidance and training from industry experts
  5. Overview of sample preparation and the analytical methodologies employed in extractables studies
  6. Detailed summary of leachables including method development and validation considerations, setting limits, and on-going screening
  7. Review of case studies with specific examples demonstrating potential sources of extractables and leachables and the impact on the drug product

This, plus the opportunity to tailor course contents specifically to your requirements during this small intimate training, ensures you'll get the knowledge you need to succeed as a business and as an individual.

Agenda

Day 1: October 17

Extractables

8:00 – 9:00 Registration, Networking Breakfast

9:00 – 10:00 Introduction to E&L

  • Definition of extractables and leachables
  • Why are they important
  • Packaging Overview
  • Determination of limits

10:00 – 11:00 Regulatory Considerations

  • Regulatory standpoints and requirements
  • Working groups and guidance documents

11:00 – 11:30 Networking Break

11:30 – 12:30 Packaging Materials

  • Discussion of polymeric and elastomeric materials
  • Polymer additives, potential impurities and the reasons for their presence
  • Review of supply chain
  • Factors affecting the migration of compounds

12:30 – 2:00 Networking Lunch

2:00 – 3:00 Extractables Analysis

  • Experimental Design
  • Component review & selection of critical parts
  • Aim of extractable study
  • Extraction methods, including solvent choice and sample preparation techniques

3:00 – 3:30 Networking Break

3:30 – 5:00 Analytical Techniques

  • What techniques are available
  • What techniques are required
  • Starting points for methods

5:00 – End of Day 1

6:00 – Evening Networking Reception


Day 2: October 18

Leachables

8:30 – 9:30 Networking Breakfast

9:30 – 11:00 Detailed Overview of Leachables

  • Setting Limits
  • Method Development and Validation Considerations
  • Leachables Study Design
  • Stability Storage

11:15 – 12:30 Networking Lunch - Q&A with Speakers

12:30 – Optional Offsite Outing to Explore the Cleveland Area

Speakers

Paul Cummings

General Manager, Smithers Rapra Analytical Services 


 

As general manager, Paul is responsible for the Smithers Rapra Analytical Services lab located in Akron to support extractables and leachables studies for the medical device, pharmaceutical and food industries. The lab also provides chemistry support to Smithers Rapra’s existing analytical and physical testing laboratories.

 

Expertise: Extractables and Leachables

Paul’s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation.  He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.

Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Most recently he was a Research Fellow and Manager of Trace Organic Analysis for Intertek Pharmaceutical Services.  He has also worked at West Pharmaceutical Services, Drugscan, GlaxoSmithKline and Merck. 

Qualifications and Accreditations

Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University.  He also served his country in the United States Army.

 

Dr. Daniel Norwood

Executive Partner, SCIO Analytical | Senior Consultant at Smithers Rapra


Dr. Norwood is a Distinguished Research Fellow in Analytical Development for Boehringer Ingelheim Pharmaceuticals, Inc., and has held senior industry positions at Magellan Laboratories and the Glaxo Research Institute. He chaired the PQRI working group on Leachables and Extractables in Orally Inhaled and Nasal Drug Products, and is currently a member of the PQRI working group for Parenteral and Ophthalmic Drug Products. He has served on the Board of the Extractables Leachables Safety Information Exchange, and is a member of the USP Packaging, Storage and Distribution Expert Committee where he chairs the subcommittee on extractables and leachables.

 

Dr Andrew Feilden

Chemistry Operations Director, Smithers Rapra specializing in Extractables and Leachables


Andrew has over 16 years’ experience supporting the pharmaceutical industry.  He joined Smithers as a consultant specialising in extractables and leachables in 2011. Prior to this, he worked for AstraZeneca – leading extractable and leachable testing and where he worked on a wide range of dosage forms. Andrew has authored regulatory documents for drug substance and container closure systems (IMPD and NDA) resulting in successful regulatory approval.

Expertise: Extractables and Leachables. Pharmaceutical analysis and trace analytical chemistry.

He is now Chemistry operation director, leading a team of industry experts split over two sites. One  site is in Leatherhead, this specialises in testing materials for food contact compliance. The other is in Shawbury which carries out extractable and leachable testing for the pharmaceutical and medical industries, specialist Gel Permeation Chromatography testing and general analytical testing.

Qualifications and Professional Accreditation

Andrew has a BSc. Chemistry (Hons) and DPhil from the University of York. He is a Chartered scientist, Scientific Advisor to IPAC-RS and ex co-chair of ELSIE group.

Alison Schweda

Principal Scientist, Smithers Rapra specializing in Migration Chemistry


As Principal Scientist, Alison is primarily responsible for process implementation, execution and conduct of projects and studies, sample preparation, extraction, analysis, and result reporting. She is based in the migration chemistry lab located in Akron, Ohio, which supports extractables and leachables studies for the medical device, pharmaceutical, and food industries.

Qualifications and Professional Accreditation

Alison has over a decade of experience in chemistry and research management in the pharmaceutical industry. She most recently worked as a research scientist at the Charles River Laboratory in Ashland, Ohio. She holds a Bachelor of Science degree in Chemistry from Hillsdale College. 

Venue & Accommodations

Hyatt Regency Downtown Cleveland 

420 Superior Ave | Cleveland, OH 44114


This year's E&L Fundamentals training course will be held at the Cuyahoga Community College, Hospitality Management Center, which is within walking distance (around 2 blocks) from the Hyatt Regency Downtown Cleveland.

Additionally, we have secured a number of rooms at a discounted conference rate of $139.00 plus tax, at the Hyatt Regency Downtown Cleveland, with all delegates required to make their own travel arrangements and accommodation reservations.    

 

Book your hotel room using the following link below or by calling the hotel at (216) 575-1234  and referencing the “Smithers Extractables and Leachables Training” course.

Click here to book your room >>>

Please contact Alyssa Perna at aperna@smithers.com with any venue or accommodations questions. 

Dr. Norwood Interview

In preparation for the Fundamentals of Extractables and Leachables training course taking place this October, we sat down with one of this year's featured speakers, Dr. Daniel Norwood, to discuss what's going on in the field of E&L.

With over 41 years of experience in chemistry and pharmaceutical research, Dr. Norwood is well recognized in the industry as one of the pioneers in E&L research. He has served on the Board of the Extractables Leachables Safety Information Exchange (ELSIE), and is a member of the USP Packaging, Storage and Distribution Expert Committee, where he chairs the subcommittee on extractables and leachables. 

What are some challenges you are currently facing in the industry?

Norwood: The industry is still facing challenges about how to deal with accomplishing E&L studies, how to actually design and do simulation studies, and when and if actual leachable studies are required on various types of drug products.  In particular, the biotechnology industry is relatively new into the E&L business and they’re concerned about things like single use bioprocessing equipment and so on.  There is still some uncertainty around how to deal with these issues in the biotechnology industry.

The uncertainties in the industry are being dealt with by standard setting authorities such as the US Pharmocopeia (USP) and other industry consortia for biotechnology in particular – the BPSA (which Smithers is a member of) and BPOG - where new standards and guidance’s are being developed – likely in the next 5 years will eliminate some of the issues concerning the industry right now

There is still a reasonable amount of regulatory uncertainty – the FDA learns from industry – there is a back and forth process that is continually ongoing with the FDA (a lot of consensus building processes that have been ongoing) – these things are not fast.  

Do you see the current administration having an impact on the E&L industry?  

Norwood: The new administration is not going to have any foreseeable effect on the pharmaceutical packaging industry – but it has had an effect on the electronic nicotine delivery systems (e-cigarette) industry, which is also concerned with E&L studies –the FDA extended certain tobacco product compliance deadlines related to the Final Deeming Rule. 

If there is any other area affected by the current administration, it will likely involve the issue of importations around China and India. It's possible that certain importation standards could change, but it’s far too early to know or speculate what the impact would be. 

What types of innovations would you like to see within E&L?

Norwood: Personally, more innovations from instrument companies that enable them to do a better job identifying and quantifying E&L.  Actually, this is starting to happen.  Various libraries are being developed by the instrument companies, and various other organizations are developing libraries as well.  Some of these libraries are proprietary and you have to pay something or join to be a part of them – but we are moving in the right direction. 

Authentic reference standards would be extremely useful to the industry in general.  

What can you gain from attending?

Norwood: Smithers has a signicant amount of expertise in E&L characterization and a number of Smithers employees have been involved in the development of best practices and standards of E&L – pharmaceuticals, electronic nicotine delivery, etc.

By attending this training course, you will have the chance to receive personalized guidance on regulations, best practices, and testing standards fom respected industry experts that are performing the studies in the labs.