Track C c-GMP Workshop (English&Chinese)
24th, June 2008
Morning:10:30-12:30 Afternoon: 13:30-17:00
Shanghai New International Expo Center E3-M22
Morning:
Outline:
“21 CFR Part 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING FOR DIETARY SUPPLEMENTS”
The FDA issued a final rule in the Federal Register June 25, 2007, establishing regulations to require current Good Manufacturing Practices (cGMPs) for dietary supplements. The regulations became effective August 24, 2007.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 requires manufacturers to substantiate the safety of their products, and this new rule establishes cGMPs to assure the potency of the product and reduce risks associated with dietary supplements that have been adulterated or misbranded.
Requirements for designing and constructing physical plants, establishing quality control procedures, testing manufactured dietary ingredient and dietary supplements, and handling customer complaints are included in this new rule.
cGMPs is a way to help ensure safer products, and this presentation will focus on the requirements as they apply to manufacturers of dietary ingredients, and will include information and requirements for:
Personnel Manufacturing Operations
Physical Plant & Grounds Packaging and Labeling Operations
Equipment & Utensils Holding and Distribution
Production & Process Control System Product Complaints
Quality Control Adverse Event Reporting
Laboratory Operations Records and Record Keeping
Components, Packaging, Labeling Electronic Records
Master & Batch Manufacturing Records Recall Procedures
You will learn how these regulations affect YOUR company and how you can be compliant with these regulations.
Good Manufacturing Practices = Good Business Practices
Speakers: Sid Rubinstein
Sid Rubinstein is a Principal in the consulting firm Regulatory Compliance Initiatives, Inc. (RCI), and has more than 25 years experience in the pharmaceutical industry, including over 18 years as a consultant. He specializes in current Good Manufacturing Practice (cGMP) regulations, Quality System requirements, and developing and directing regulatory corrective action initiatives.
As a consultant, Sid founded MediPharm International Consultants, Ltd., a firm specializing in performing audits of US and foreign pharmaceutical manufacturers of active pharmaceutical ingredients, all finished dosage forms, dietary supplements and nutraceuticals, and biotechnology products.
He has successfully prepared clients for FDA Pre-Approval Inspections (PAI), and has directed clients in the preparation of Standard Operating Procedure (SOP) and Quality System Manuals, as well as Corrective and Preventative Action (CAPA) Programs.
Sid was also a founder and a Principal in HP BioPharm Technologies, Ltd. and Cox & Fay, Inc., companies dedicated to working with US and foreign firms requiring assistance with drug development and clinical research project management, and with plans for designing new turnkey manufacturing facilities, respectively.
Prior to his consulting career, Sid was Vice President-Operations and Compliance for Dell Laboratories, Inc., Edward Mendell Company, Inc., and The Vitarine Company, Inc.
Sid has a BS degree in Pharmacy from Columbia University College of Pharmaceutical Sciences, and has practiced community pharmacy.
Afternoon:
1
Outline：Validation of Compendial Procedures
Abstract:
The new Validation of Compendial Procedures will comprehensively address USP’s validation requirements. The student will have an opportunity to define the characteristics of validation procedures, design experiments to consider those characteristics and interpret the results using a statistically-based methodology. The distinctions between verification and validation will be reviewed and the requirements for validation of alternative methods will be addressed.
Speaker：
V. Srini Srinivasan, Ph.D., is Vice President of the United States Pharmacopeia Verification Programs and International Site support.
In his capacity as Vice President of Verification Programs and International Sites Support, Dr Srinivasan is the major coordinator to oversee the USP Verification Programs. He developed the USP Verification Programs per US FDA regulations and ICH Q7A Guideline. Meanwhile Dr Srinivasan coordinated the activities of establishing the USP International sites in India (2005) and in China (2006).
Prior to assuming his current assignment , Dr. Srinivasan served as USP’s Director of the Dietary Supplements and was responsible for assisting the USP Council of Experts in establishing public standards for over-the-counter drugs, vitamins, minerals, amino acids, botanicals, and for products containing these substances.
2
Outline：Ross ERP Support for C-GMP Achievement for pharma plants（Case Study）
Speaker：
Edmund Lau, Vice President, Great China, CDC Software
Edmund Lau is responsible for sales, services and business development in Greater China (Hong Kong, Taiwan and China) as vice president.
Mr. Lau holds a bachelor’s degree in computer science from Shanghai Jiao-Tong University and a master’s in computer science from University of Southern California.
Track D c-GMP Workshop (English&Chinese)
25th, June 2008
Morning:10:30-12:30 Afternoon: 13:30-17:00
Shanghai New International Expo Center E3-M22
Morning:
Outline:
- Content validation:
Multi-Purpose Plant Validation (in detail)
Computer Validation and Revalidations (in detail)
Purified Water System Validation (in detail)
LC validation, Clean Room Validation
High Potency Process Validation
- Validation Master Plan, URS
- Facility IQ and OQ
- Prospective Validation, Concurrent Validation and Respective Validation
- Batch and validation
Demonstration batch and validation batch
DQ, IQ, OQ, PQ and their Protocols
Speaker: Dr. Allan Hong
Dr. Allan Hong, Allan Hong, Consultant, China cGMP Group
Dr. Hong has many years EU and US pharmaceutical industrial experience in API development, process scale up, and production experience. He also has hands on experience in dealing with EDQM and FDA’s inspections. He was once in charge of a European pharmaceutical company’s worldwide outsourcing activities to inspect many API manufacturing companies in China, Asia, Europe, North American and South America. Currently, Dr. Hong is an authorized cGMP auditor based in China for many European and US pharmaceutical companies whom also helps many Chinese pharmaceutical companies for EDQM and FDA’s inspections in China.
Dr. Hong graduated from University of Delaware (USA) with a BS degree in chemical engineering. He also graduated with MS, Master of Philosophy, and Doctor Degrees from Yale University.
Afternoon:
Title:
How to successfully comply with EU and FDA cGMP for the manufacturing of APIs and excipients a workshop consisting of theory and practical case studies.
What you will learn:
- The importance of implementing an optimal system of cGMP。
- Basic principles of a quality management system working under the control of GMP. GMP
- Regulatory expectations and differences between FDA and EU requirements.
- Audits as an effective tool to manage a quality management system under GMP.
- Benefits of using 3rd party auditing companies.
The workshop will comprise of a lecture to update all the participants on general aspects of GMP requirements of manufacturers of Active Pharmaceutical Ingredients according to US FDA and EU EMEA GMP regulations. The practical implementation of effective quality management principles will be practiced during case studies of GMP situations that actually did happen in manufacturing plants for Active Pharmaceutical Ingredients and Excipients.
Speaker: Eize de Boer
Eize de Boer
Global Manager Life Science Auditing at SGS Systems & Services Certification
PhD in biochemistry from University of Amsterdam
Oversees creation / project management of 2nd & 3rd party auditing & training programs in- and for the life sciences industry. Previous site director for Wyeth Pharma and several roles at Solvay Pharmaceuticals in Process Development and Manufacturing. Development of a wide range of pharmaceutical quality management systems.
