2019 Archived Content

DAY 1: 2:00 - 5:30 PM | DAY 2: 8:15 AM - 6:05 PM
Room: Aqua 303

TS11B: GMP and Validation Requirements for Biologics Processes – Phase 1 through to Commercial Manufacturing

Workshop Agenda

This seminar looks at the current requirements and expectations for GMP manufacturing and testing at all stages of the product lifecycle, from Phase I through all clinical phases to commercial manufacturing and maintaining validated status. It will cover phase-appropriate GMP and the evolution of the pharmaceutical quality system to address the requirements at different phases of development and of the commercial product lifecycle. It will also look at how the challenges can vary for different types of biological products. Topics covered will include the regulatory background, process and analytical development, process knowledge, and the impact of single-use systems, process qualification, continuous process verification, and specific considerations for challenging and/or unusual processes, including live vaccines and cell therapy products.


Trevor Deeks, PhD, QA/QC and GMP Consultant, Deeks Pharmaceutical Consulting Services, LLC

Day 1 - Tuesday January 15, 2018

2:00 – 2:30 Introductions and Course Objectives Interactive

2:30 – 3:15 What is Phase Appropriate GMP? – At What point does GMP start in the process? - The Regulatory Background Presentation

3:15 – 3:45 Process Development and Process Mapping Presentation and Interactive

3:45 – 4:30 Coffee Break in Exhibition Hall with Poster Viewing

4:30 – 5:30 Process Mapping and Risk Assessment Group Exercise

5:30 End of Day 1

Day 2 - Wednesday January 16, 2018

08:15 – 09:00 Report Back on Group Exercise and Q & A Interactive

09:00 – 09:50 Analytical Development, Qualification and Validation Presentation and Interactive

09:50 – 10:35 Coffee Break in Exhibition Hall with Poster Viewing

10:35 – 11:00 The Challenges of Outsourcing Presentation

11:00 – 12:15 What does the Contract Giver’s Quality System Require? How will this be different to in-house manufacturing? How will it develop and mature as the product goes through different clinical phases? Interactive/Group Exercise

12:15 – 1:30 Lunch Provided

1:30 – 2:00 Challenging Processes - Live vaccines and ATMPs Presentation

2:00 – 2:30 Single-use Technologies Presentation

2:30 – 3:05 Phase 3 and Commercial Manufacturing – What additional procedures, systems and controls are required? How should you prepare for Process Performance Qualification (PPQ) and Continuous Process Verification? Automating the Quality System Presentation

3:05 – 4:00 Refreshment Break in Exhibition Hall with Poster Viewing

4:00 – 5:00 Facility Readiness for PPQ and Commercial Manufacturing, Planning the PPQ activities Group Exercise

5:00 – 5:15 Report Back on Group Exercise Interactive

5:15 – 5:50 Dealing with Deviations from PPQ, Continuous Improvement Programs, Maintaining Validated Status, Annual Product Review and Maintaining Data Integrity Presentation

5:50 – 6:05 Q & A - Wrap up of Day 2 Interactive

6:05 Networking Reception in the Exhibit Hall

Instructor Biography:

Deeks_TrevorTrevor Deeks, PhD, QA/QC and GMP Consultant, Deeks Pharmaceutical Consulting Services, LLC

Trevor has 39 years of experience in pharmaceutical development, manufacturing, quality control and quality assurance. He is registered as an eligible QP under EC Directive and has also practiced as a registered Pharmacist in the UK. He now resides in Maryland and has his own consulting business. He has a PhD in Peptide Chemistry and has extensive expertise in aseptic processing, and in a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cell-based products.

He has practiced as a QP since 1983 and his QP experience includes commercial batch release, investigational medicinal products and “Specials.” He has established and operated Quality Systems in compliance with the European Clinical Trials Directive and with global regulatory expectations (FDA, WHO, ANVISA, etc.). He has led scale-up and technology transfer projects for large and small molecules, has managed many projects with contract manufacturing organizations, has undertaken a number of evaluations of new technologies, and has performed due diligence evaluations of such products for acquisition.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.