- GACP/GMP (SYD 13/11/19)
9:00 am - 4:00 pm
GACP (Good Agricultural and Collection Practices) and EU GMP (Good Manufacturing Practices)
Introduction to regulations and compliance in the medicinal cannabis industry.
Discussion of quality management systems (QMS), including hygiene, what makes a batch, batch traceability, basic record keeping (Good Documentation Practices or GDocP), quality risk management and Corrective and Preventive Actions (CAPA)
- Good Agricultural Practice GAP (pre-harvest)
- EU Good Agricultural Practice – GAP guidance
- WHO Good Agricultural & Collection Practice – GACP guidance
- Part 1 – Good Manufacturing Practice (final dosage forms) and Part 2 – Good Manufacturing Practice (Active Pharmaceutical Ingredients)
Understand the common GMP requirements for both APIs and final dosage forms.
- Global regulatory landscape
- GMP main requirements including:
- Pharmaceutical Quality System
- Personnel requirements
- Facilities and equipment
- Documentation (Data Integrity)
- Quality control (inc. Trending and Out of Specifications (OOS)
- Outsourced activities
- Complaints and recalls
- Internal audits
Annex 7 – Herbal medicinal products (flower products)
Venue Phone: + 61 2 9491 9950
Venue Website: https://www.edengardens.com.auAddress:
North Ryde Eden Gardens
The landmark North Ryde centre is a member of SUVA (Sydney Unique Venue Association).
Join PharmOut for training sessions in gorgeous garden surroundings that create a relaxing learning environment. Networking events and fully catered lunches are held in the unique outdoor garden settings, including several lawns and terraces and the garden theatre.
All function rooms are equipped with AV equipment and facilities.
The onsite undercover car park has over 200 car spaces and two coach bays.
The functions rooms are equipped with wireless broadband internet.
A variety of different accommodation options are available near to Eden Gardens.