CBE Overcomes Covid-19 Challenges To Deliver GMP Training in Hong Kong

Training March 2020

CBE Overcomes Covid-19 Challenges To Deliver GMP Training in Hong Kong

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In our current and changing environment the need for flexible learning options is ever present. The Chinese University of Hong Kong (CUHK) and the School of Biomedical Sciences engaged with CBE to deliver a Biopharmaceutical, Pharmacopoeia and Accreditation course. The course was designed to deliver an in-depth technical program that provided a fundamental basis for the graduates to take their place in industry as future leaders and Authorised Persons.

The course was planned for delivery in January through to April using a mix of online delivery and face-to-face lectures. As the impact of Covid-19 hit the region and travel became restricted, all lectures were adjusted to online remote delivery in February. Through close cooperation between CBE and Dr Ann Lau from the CUHK we managed to deliver the course according to schedule. We used a combination of Zoom meeting software and Quitch, an Australian developed educational management and delivery portal, and were able to deliver the program's 12 modules seamlessly.

CBE was selected based on our unique mix of industry biopharmaceutical experience in this area coupled with our long and successful track record regionally of delivering high quality GMP related training to industry.

The course originated from three key drivers

  1. The Hong Kong government is encouraging the rapid development of Advanced Cell Therapies in the SAR and have recognised that future leaders in this space need a solid grounding in biopharmaceutical quality and GMP regulations.
  2. The Chinese government has designated the region encompassed by Guangzhou, Hong Kong and Macau as an advanced technology region, including the development of biologics and cell therapies.
  3. The Hong Kong Department of Health recently updated specific guidance on the training and experience requirements for HK Authorised Persons.

With these key drivers in place, the learning objectives were developed and focussed on:

  1. Acquiring an overview of the worldwide quality standards and policies on drug manufacturing, understanding the relationship between the quality standards and the accreditation agencies, and the importance of compliance with the quality standard for medicines.
  2. Understanding Quality Control, the role of pharmacopeia in quality control, and how the Quality Assurance system is designed and operated in biopharmaceutical manufacturing.
  3. Recognising the challenges between development and commercialisation of advanced therapies.

The course content included the following modules:

Module

CBE Lecturer

1.

International Biopharmaceutical Regulation and GMPs

Mr. Steve Williams

2.

Quality Management and the Pharmaceutical Quality System (PQS)

Ms. Justine Mann

3.

Role and Responsibility of the Authorised Person

Guest Lecturer:

Dr. Celine Cheng

4.

Introduction to Drug Development and Clinical Trials

Mr. Steve Williams

5.

Drug Registration and Regulatory Pathways and Commercialisation

Mr. Steve Williams

6.

Challenges in Biological Drug Development

Dr Jeff Davies

7.

Manufacturing Controls (General) and GMPs

Ms. Justine Mann

8.

Manufacturing Controls – Biologics and Sterile Products

Mr. Steve Williams

9.

Quality Control – Part A (Pharmacopeial Requirements)

Mr. Steve Williams

10.

Quality Control – Part B (Microbiological)

Ms. Justine Mann

11.

Qualification and Validation

Mr. Maurice Parlane

12.

Facility Design, Cleanrooms and Critical Services

Mr. Andrew Watson

The training delivery enabled an interactive opportunity to work with students and provide fundamental industry knowledge. We look forward to watching the graduates take their place in industry and further continuing our association with the CUHK and working with future graduates.

Coauthors: Steve Williams and Justine Mann – CBE Partners and Senior Consultants.