Join This Important, Two Day Comprehensive & Interactive Course with Discussions on:

• GMP considerations related to ICHQ7
• History of API GMP Development
• Requirements and Implementation of ICHQ7
• Costs and benefits of manufacturing excipients in compliance with ICHQ7A guidelines
• Quality Management and Creating Quality Units
• Records and Documentation
• Differences in Registration for Market Authorizations
• Material Management
• Managing Complaints and Recalls
• Impact of ICHQ7 on Second and Third Parties
• Evaluation of Suppliers
• Cleaning Validation
• Labeling of APIs and Intermediates
• GMP in Laboratory Control
• Change Control
• Differences between API’s manufactured by Cell Culture(&)/ Fermentation to API’s manufactured by Chemical Synthesis
• Audit Preparation with Consideration to GMP and ICH Requirements

As of 30th October 2005 EU law mandated manufacturers of medicinal and veterinary products for sale in the EU to use only APIs that have been produced in compliance with GMP (ICHQ7a). It is important that API production facilities operating under different national and international regulatory authorities not be required to meet diverse standards. For this reason, an Expert Working Group in ICH developed the ICH-Q7 document as a single standard that all suppliers must apply to production of APIs used in human drug products manufactured in any of the ICH signatory regions.

Mr. Michael H. Anisfeld President Globepharm

Michael H. Anisfeld is a senior consultant for Globepharm Consulting specializing in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies (WHO, UNFPA, UNIDO), national regulatory agencies (including the US-FDA, Australian TGA) and over 260 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in the Americas, Africa, Europe and Asia.

Mr. Anisfeld has established and directed quality control, quality assurance, production, research and development administration, materials management and supply chain functions in the industry, and has instituted innovative, cost-effective auditing programs for his clients, ensuring they pass regulatory inspections first time.

Performing over 25 full scale mock inspections annually (to United States FDA, British MHRA, Canadian HPFBI, Australian TGA, and ISO 9000 standards), including audits whose reports are evaluated directly by national regulatory agencies as part of product approval, Mr. Anisfeld has served on both sides of the fence:Inspector and Inspectee.

With over thirty-five years expertise in the healthcare industry, he has held senior management positions in International Technology Transfer, Quality Assurance and Production and in the course of his career, he has designed pharmaceutical, medical device and active pharmaceutical ingredient (API) facilities in seven countries. A member of the adjunct faculty of the University of Illinois, where he lectures in Pharmaceutical Technology and Drug Quality issues, Mr. Anisfeld holds higher degrees in Pharmaceutical Technology (M.Sc.), Business Administration (MBA), Management (MSM) and holds a Diploma in Middle Eastern Studies (DMES).

An active member of many European and American regulatory and technical associations, he has served on the Board of Directors of the Parenteral Drug Association, and been Chairman of its Quality Control and Aseptic Processing Task Groups. An acclaimed International lecturer on the subject of GMP and Quality topics, Mr. Anisfeld is also a prolific author on these topics. He is the editor/author of many books on the subject including: "International Drug GMPs", “International Device GMPs”, “Keyword Guide to 21CFR”, “Guide to FDA International Inspections”, "Sterile Pharmaceutical Manufacturing", and PDA's monograph "Validation of Aseptic Processing of Liquid Drug Products", and “International Comparative Pharmacopoeia”. He is currently Vice President of the Industrial Pharmacy Section of the International Pharmaceutical Federation (FIP).

He consults with companies, professional associations, international organizations and governments worldwide on all matters pertaining to Good Manufacturing Practices (GMP), Good Warehousing/Distribution Practices (GWDP) and Quality Assurance Systems in the pharmaceutical and medical device supply chain. He provides “expert witness” testimony in court cases involving the implementation and interpretation of pharmaceutical GMPs and medical device QSRs; and for several years has donated four weeks a year probono working with government agencies and professional associations in lesser developed nations to improve drug quality in those countries (including Cuba, Ghana, Kenya, Mongolia, Nigeria, and Sri Lanka).

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Tuesday August 17, 2010		Wednesday, August 18, 2010
8:00 AM	Registration and Continental Breakfast	8:00 AM	Continental Breakfast
8:30 AM	Course Begins	8:30 AM	Course Continues
10:15 AM	Mid-Morning Refreshment Break	10:15 AM	Mid-Morning Refreshment Break
10:30 AM	Course Continues	10:30 AM	Course Continues
12:00 PM	Luncheon	12:00 PM	Luncheon
1:15 PM	Course Continues	1:00 PM	Course Continues
2:45 PM	Mid-Afternoon Refreshment	2:30 PM	Questions & Answers
3:00 PM	Course Continues	3:00 PM	Conclusion of the program
4:15 PM	Questions & Answers
4:30 PM	Conclusion of Day 1

Day 1 - Tuesday August 17, 2010
08:30 AM - 04:30 PM	Background and History What is ICH and who negotiated Q7A? Why is there so much detail included in the guidance? How did we get to Q7A – sharing insider information Is it truly an international guidance? Section 1 - Introduction Applying Q7A in the real world Where does an API process begin? Why is it important to identify the API Starting Material? Section 2 - Quality Management Responsibilities of Quality and Production Activities What Quality responsibilities can or cannot be delegated? Section 3 - Personnel Qualification and Training Hygiene Use of Consultants Section 4 - Buildings and Facilities Design and Construction Utilities Section 5 and 12.7 - Process Equipment and Cleaning Validation Equipment Design and Construction Cleaning in an API Process Validation of API Cleaning  Section 6 - Documentation and Records A Documentation System should exist What types of Records should exist and what Reviews and Approvals are expected? What Production and Laboratory records are necessary? Section 7 - Materials Management What types of procedures are needed? What Material Management procedures should exist? Section 8 - Production and In-Process Controls Critical Operations – What is critical? Yields – The behind the scenes discussions about this item. Deviations – Documentation and Investigations expected Section 9 - Packaging and Identification Procedures and materials Label issuance and controls expected Labeling of APIs and Intermediates Section 10 - Storage and Distribution Warehouse and Storage records Distribution and Transfer expectations Transport and Labels
Day 2 - Wednesday, August 18, 2010
08:30 AM - 03:30 PM	Section 11 - Laboratory Controls Are there any differences between API and Drug Product requirements? What should records document? Reference Standards discussed Why is an impurity profile important? Stability programs Section 12 and 19.6 - Process Validation What process validation is NOT! What types of validation is acceptable for API What flexibility exists for API? Section 13 - Change Control When is change control needed? Notification requirements Section 14 - Rejection and Reuse of Materials What is the difference between reprocessing and rework? Be careful what you call it! Material recovery expectations What are acceptable practices? Section 15 - Complaints and Recalls Are there any specific requirements? Section 16 - Contract Manufacturers (Including Laboratories) What does Q7A expect for the use of contract manufacturers What responsibility does the holder of the drug authorization or NDA retain under Q7A? Section 17 - Agents, Brokers, Traders, Distributors, Repackers, and Relabellers Why does this section even exist? Why did the Experts that negotiated the guidance include these requirements? Why is communication critical? Section 18 - Cell Culture/Fermentation Why was this section even written? Is this section “information” or a “requirement”? Section 19 - APIs For Use in Clinical Trials        Is this section appropriately titled? Why was it written? What was the true intention of the Experts that wrote and negotiated the guidance?

This two-day, comprehensive training workshop is designed for all persons involved in the manufacture of APIs (either chemically, or by cell culture/fermentation) especially for persons from:

• Quality Assurance
• Quality Control
• Pilot and Commercial Production
• Auditors of the Manufacturing Authorization Holders
• Regulatory Affairs
• Qualified Persons
• Technical Services
• Process Development
• Engineering
• Validation
• Purchasing
• Training
• Contract Laboratory & Manufacturing
• Consultants

3 easy ways to register!

Mail: International Pharmaceutical Academy 420 Highway# 7 East, Box 82022 Richmond Hill, Ontario Canada L4B 3K0

Fax: (905) 472-1819

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Cancellation/Substitutions Policy:

All cancellations are subject to a CAD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

Hilton Garden Inn Montreal Airport 7880 Côte de Liesse St. Laurent, Montreal, Quebec, Canada H4T 1E7 For reservation please contact: Tel: 514-788-5034 or 1-866-788-2518 http://hiltongardendorval.com/
A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention International Pharmaceutical Academy to receive the reduced room rate. For more information, please call us at 416-410-7402 or enquiry@ipacanada.com