Sterile products regulation and guidance training

Learn from PharmOut's own, world expert Gordon Farquharson

Course outline

This two-day intensive course will update pharmaceutical and medical device professionals with the latest global regulations governing clean room standards, guidance and regulations. They will also learn practical strategies to ensure compliance to those regulations and be able to discuss challenges and questions they currently have in the area.

Day 1	Facts, figures, references
	Current PIC/s code of GMP, 16th August 2002, Annex 1
	PIC/s Annex 1 – Essential features
	US FDA guidance vs PIC/s guidance – The essential differences
	Update on China’s SFDA GMP publication and implementation plans.
	China SFDA Sterile Products GMP Annex intentions.
Day 2	The role and update of ISO 14644-1 & 2 in the context of the sterile GMPs.
	Status and review of PIC/s PI 032-1 1 December 2009 “Recommendation – GMP Annex 1 Revision 2008, interpretation of the most important changes for the manufacture of sterile medicinal products”.
	Workshop sessions Classification of classified areas Design, configuration and implementation of facility monitoring systems: Annex 1 Section 15. in the current Pharmaceutical GMP code requires "The monitoring of Grade C and D areas in operation should be performed in accordance with the principles of Quality Risk Management." This and other quality risk issues relating to critical services will be discussed.
	Current hot topics: Control of capping operations. HEPA filter systems. BMS vs FMS systems and the validation implications.
	Questions and discussions - Gordon has a talent for distilling complex issues and concepts into plain English. This, combined with his depth of technical knowledge and practical experience, allows him to provide expert analysis of issues that you may be facing.

Bookings >>

Locations

Perth

Date: 11-12th Feb 2010
Time: 9 am to 4:30 pm
Venue: Burswood on Swan, 1 Camfield Drive, Burswood

Sydney

Date: 15-16th Feb, 2010
Time: 9 am to 4:30 pm
Venue: Eden Gardens, Cnr Lane Cove Fontenoy Rd, North Ryde

Melbourne

Date: 18-19th Feb 2010
Time: 9 am to 4:30 pm
Venue: Bruce County Hotel, 445 Blackburn Rd, Mt Waverley

Pricing

The cost for the 2 day course is $980 + GST per person. This includes lunch and refreshments.

About the trainer

PharmOut's Gordon Farquharson is widely recognised as a world leader and expert in sterile products manufacture, clean room design and maintenance and utilities for the same.

Gordon is the Chair of British, CEN and ISO committees responsible for development and deployment of the ISO 14644 family of cleanroom standards.

He is also an advisor to the EMeA concerning the revision to Annex 1 of the EU GMP in February 2008 and a member of the WHO expert committee (WHO Pharmaceutical Water GMP; Sterile GMP Annex 1).

His experience includes years at the coal face of pharmaceutical and medical device manufacture, with strong experience in processes, facilities, and critical utilities. He has held senior roles in the fields of design, construction, quality & safety management, validation and regulatory compliance.

His area of interest is the conversion of GMP principles and philosophies into a reliable operational assets. His technical expertise is associated with the controlled environment and critical utilities for product manufacture and safety critical systems.

Gordon has also conducted a broad spectrum of international audits, inspections, and training assignments; encompassing technical aspects, GMP compliance, and operational due diligence.