6 October 2021 Seminars

9:15 am - 9:35 am

Engaging Management With Their Regulatory Obligations

9:15 am - 9:35 am

IPEC Co-Processed Excipient Guide for Pharmaceutical Excipients

9:15 am - 9:35 am

Problem Solving Tools

9:15 am - 9:35 am

Use of Recombinant Human Albumin in Advanced Therapy Medicinal Products

Speaker

9:30 am - 9:45 am

A Quick Overview of Visual Quality Control in Pharma Production and Packaging

Speaker

9:35 am - 9:55 am

Best Practises for Selection of Excipients for Paediatrics – Workshop Reflection

9:35 am - 9:55 am

Bridging The Gap Between Discovery and Development – DMPK Influence

Speaker

  • View full profile for Dr Richard WeaverDr Richard Weaver Senior Vice President - Pre-Clinical Development - Sygnature Discovery
9:35 am - 9:55 am

The Obligations Of The WDA Licence Holder

Speaker

9:55 am - 10:15 am

Current Trends in Microbial Monitoring of Aseptic Manufacturing Areas

Aseptic manufacturing in Grade A environments has traditionally been controlled microbiologically using interval type sampling. Rather than just sampling 1 cubic metre of air by active air sampling, new methods allow for continuous microbial monitoring throughout an entire production cycle, with minimum human intervention, both by the use of traditional TSA agar plates employed over longer periods and by real time microbial monitoring. These methods meet the current thoughts as outlined in the proposed Annex 1 revisions.

9:55 am - 10:10 am

Digital Work Instructions: Human Factors

Speaker

9:55 am - 10:15 am

Organisational Culture, The Hidden Driver of Compliance

9:55 am - 10:15 am

QbD is not Just DoE

Speaker

9:55 am - 10:15 am

QbD is not Just DoE

Speaker

9:55 am - 10:15 am

The Need For And Issues With Introducing New Excipients to the Market

10:15 am - 11:30 am

Break

10:20 am - 10:35 am

How Robotics Are Impacting Aseptic Filling

Speaker

11:15 am - 11:35 am

Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

11:30 am - 11:50 am

Data & IIoT – Changing How We Do Maintenance and Manufacturing in Pharma 4.0

Speaker

11:30 am - 12:30 pm

Good Distribution Practice and How The ECA / PQG Monographs Can Help You

Speaker

  • View full profile for Phil ButsonPhil Butson Director, R&D Quality Futures - Glaxo SmithKline
11:30 am - 11:50 am

Pediatric and Geriatric Formulations: Common Challenge

Aseptic manufacturing in Grade A environments has traditionally been controlled microbiologically using interval type sampling. Rather than just sampling 1 cubic metre of air by active air sampling, new methods allow for continuous microbial monitoring throughout an entire production cycle, with minimum human intervention, both by the use of traditional TSA agar plates employed over longer periods and by real time microbial monitoring. These methods meet the current thoughts as outlined in the proposed Annex 1 revisions.

11:30 am - 12:00 pm

Securing The Supply Chain, EXCiPACT Developments

11:35 am - 11:55 am

Pharmaceutical Packaging in the Digital Age

11:40 am - 11:55 am

Semi-prep SFC development via cross-pharma collaboration

Speaker

11:50 am - 12:10 pm

Climate Change Challenges

11:55 am - 12:15 pm

Serialisation in 2021 – Delivery and Challenges

12:00 pm - 12:30 pm

Experiences With Remote EXCiPACT Audits

Speaker

12:05 pm - 12:20 pm

From Lab to Production

Speaker

12:10 pm - 12:30 pm

Proactive Programme to Avoid Contamination

Speaker

12:10 pm - 12:30 pm

Using Excipient Science to Help Protect Moisture Sensitive Drugs

Speaker

12:15 pm - 12:35 pm

Making Pharmaceutical Packaging that is Easy for Elderly People to Open

12:30 pm - 12:50 pm

Catalytic Combustion Online-TOC Analysis For The Rapid Verification of CIP Processes

TOC analysis is a common and proven tool for the verification of CIP processes in the pharmaceutical industry. While the technology itself delivers fast measurement results, time necessary for grab sampling, transport to laboratory, analysis, data evaluation and finally release has a negative impact on the availability of CIP and production equipment. The use of process analyzer technology (PAT) has the potential to accelerate release processes. To realize major time savings in the verification of CIP processes, Shimadzu has therefor developed concepts with partners from the pharmaceutical industry, taking a novel approach to the use of catalytic combustion Online TOC in this field.

Speaker

12:35 pm - 2:00 pm

Break

12:50 pm - 2:00 pm

Break

12:55 pm - 1:10 pm

Overcoming Key Challenges in Early Oral Formulation Development

Speaker

1:20 pm - 1:35 pm

Design and Build – Phased Design of Controlled Environments in Pharmaceutical Manufacturing Facilities

Speaker

1:45 pm - 2:00 pm

Conducting effective remote audits: Do’s & Don’ts

Speaker

2:00 pm - 2:40 pm

Tablet Disintegrants – Understanding Mechanisms and Selection Criteria

The "Big Three" super-disintegrants (CCS, cPVP, SSG) exhibit very distinct disintegration mechanisms. Understanding these mechnisms in the context of tablet matrix properties, such as solubility and hydrophilicity, is essential for the successful formulation of tablets.

Speaker

  • View full profile for Dr Gernot WarnkeDr Gernot Warnke Pharmaceutical and Personal Care Business Manager - JRS Pharma
2:00 pm - 2:20 pm

The Impact of Data Science in Clinical Research

2:00 pm - 2:20 pm

Using Vacuum Evaporation to treat Pharmaceutical Wastewater

Speaker

  • View full profile for Kalpesh ShahKalpesh Shah Industrial Sales Manager - Veolia Water Technologies
2:00 pm - 2:20 pm

Vitamin D: a Clinical Science Update on the Efficacy of High Dose treatment

Vitamin D is perhaps more correctly thought of as a hormone. It remains an extremely popular subject of clinical trials globally. However, governmental intake recommendations are based on the avoidance of severe deficiency and the onset of symptoms such as rickets. They also often fail to take into account the exposure of the skin of their populations to sunlight throughout the year. To have a benefit in many pathologies, much higher doses of Vitamin D are required. This paper will review the current use of adjunctive therapies untilising high dose Vitamin D.

2:20 pm - 2:40 pm

Code of Practice for Dealing with Relational Risk in Clinical Research

Speaker

2:20 pm - 2:40 pm

If APIs go wrong – managing delays, typical problems and quality claims

If you have never had a problem with an API it’s probably safe to say you just haven’t had a problem yet.

In this presentation we’ll take a look at some real-life examples of things that can go wrong and how you might prepare and mitigate:  shipment delays; service complaints; transit damage; insurance responsibilities; Quality claims; post-Brexit import issues etc.

Problems can be a black-hole of time to fix so it’s wise to be as forewarned as you can be!

2:20 pm - 2:40 pm

Integrating X-ray Technology Into Production

Speaker

2:20 pm - 2:40 pm

Nitrosamines Issue: Is Your Company Impacted?

- A background on the nitrosamine contaminants

- Impacted products

- Regulatory requirements with reference guidelines

- Timelines on actions that need to be taken by MA holders

2:20 pm - 2:40 pm

Presentation Skills

2:40 pm - 3:00 pm

GMP Obligations for the Marketing Authorisation Holder

The pharmaceutical manufacturing sector is increasingly working to an outsourced model where the MA Holder is a virtual (office based) entity, without any traditional manufacturing or testing activities on site.
This leads to the false assumption that GMP/GDP do not apply to the MA Holder facility (of course they do).
The EMA have published a reflection paper on GMP for Marketing Authorisation Holders; here are some practical steps an MAH can take to ensure compliance without overloading current systems.

2:40 pm - 3:00 pm

Implementation of Clinical Trials Regulation

2:50 pm - 3:00 pm

Tablet Defects: Can They Be Predicted?

Common tablet defects include chipping, picking & sticking, cracking, lamination & capping to name a few. Lamination & capping often occur during scale-up and are main issues in our industry. It is a common hurdle in tableting which is not generally observed during the R&D development phase. One of the reasons lie in the high production speeds on industrial rotary presses, speeds that are not generally seen on conventional R&D tablet presses. This explains why capping or lamination is sometimes only discovered during scale-up. It is essential to try to identify those issues at the very early stage of development.

3:00 pm - 4:00 pm

Break & Exhibition

3:20 pm - 4:00 pm

Break & Exhibition