UpcomingPerth PIC/S PE009 GMP – $13.00

Perth PIC/S PE009 GMP – $13.00

The PIC/S Code of GMP for the manufacture of medicinal products PE 009 version 13 which came into effect in January 2017 we re offering a 1 day training course covering the essential “what you need to know“.

New PIC/S GMP version 13

The TGA finally formally announced adoption of the latest PIC/S GMP Guide version 13 (PE009-13, 1 January 2017) which is scheduled to commence on 31 December 2017!

In this public statement the TGA announced from 1st January 2018, the TGA GMP inspectors will use the new GMP Guide during inspections.

Compliance with the requirements of the latest PIC/S GMP Guide (PE009-13, 1 January 2017) will be expected from this adoption date; however, inspectors will take a pragmatic approach to discussing and reporting and we are seeing them already reporting deficiencies.

12 month, graduated transition period will be provided to allow manufacturers time to assess the new supplementary requirements contained in the new Manufacturing Principles and implement changes to procedures and practices to fully comply with the new guide.

Full compliance with the PIC/S Guide to GMP (PE009-13, 1 January 2017) will be expected after this 12 month transition period ends, 1st January 2019!

Read more here on the PIC/S version 13 GMP training.

  • PIC/S GMPs (PER-19-10-17)
    19 October 2017
    9:00 am - 4:00 pm
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Location

Venue:  

Venue Phone: +61 8 9221 1200

Venue Website:

Address:
221 Adelaide Terrace, Perth, Western Australia, 6000, Australia

Description:

Novotel Perth Langley

Novotel Perth Langley hotel is within walking distance of Perth’s vibrant shopping malls, restaurants, pubs, the beautiful Swan River and many other tourist attractions nearby, plus free city bus transport on your doorstep. Explore further afield to bustling Fremantle or Rottnest Island via train, bus or ferry.Outside of the hotel, Perth and its beautiful parks and gardens are waiting to be explored.The Novotel Perth Langley is less than 20 minutes from the Airport by car.

Internet Access

Wireless broadband is available in all conference rooms and public areas.

Car Parking

Undercover car parking is available on site.

Accommodation

Novotel Perth Langley hotel boasts 256 guest rooms and suites including Standard Rooms, 1 Bedroom Apartments, Perth Spa Suites and Deluxe Suites.

City: Perth, Western Australia

Perth, capital of Western Australia, sits where the Swan River meets the southwest coast. Its suburbs lie along sandy beaches, and the huge, riverside Kings Park and Botanic Garden on Mt. Eliza offer sweeping views of the city. The Perth Cultural Centre houses the state ballet and opera companies, and occupies its own central precinct, including a theater, art galleries and the Western Australian Museum.