Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.

TUESDAY, JANUARY 21 - WEDNESDAY, JANUARY 22

TS9B: GMP and Validation Requirements for Biologics Processes – Phase I through to Commercial Manufacturing

Aqua 310A

DAY 1: TUESDAY

2:00 - 5:30 pm Seminar Sessions

DAY 2: WEDNESDAY

8:15 am - 6:05 pm Seminar Sessions

12:15 - 1:15 pm Lunch Provided
6:05 - 7:00 pm Networking Reception in the Exhibit Hall with Poster Viewing

Exhibit Hall Refreshment Breaks also provided.

Instructor:

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

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.

Day 1

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 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 - 5:30 Process Mapping and Risk Assessment (Group Exercise)

5:30 Close of Day 1

Day 2

8:15 - 9:00 Report Back on Group Exercise and Q&A (Interactive)

9:00 - 9:50 Analytical Development, Qualification, and Validation (Presentation and Interactive)

9:50 - 10:35 Coffee Break in the Exhibit 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 III 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)

Instructor:

Trevor 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.

WHAT IS A TRAINING SEMINAR?

Each CHI Training Seminar offers 1.5 days of instruction, refreshment breaks, exhibit hall functions, and lunch for all registered attendees on the full day of the class. Each person registered for the Training Seminar will be provided with a hard copy handbook for the Training Seminar in which they are registered. A limited number of additional handbooks may be available for other delegates. CHI encourages track hopping between conference programs, and we ask that Training Seminars not be disturbed once they have begun. We ask that attendees commit to attending the entire 1.5-day training, and not engage in track hopping once the class has started.