Regulatory Workshop for Developing Practical Skills
 

Workshop - Sunday, 27 April 2008
09.00	Registration and Coffee
09.30	Opening remarks
09.40	Ensuring Good Manufacturing Practices for Drug Products CGMP General Provisions Process Control Packaging Control FDA/EMEA Policy and Program Issues Compliance Programs Guidance Documents Philip Lofty, Vice President, Business Development  Pharmaceutical Services Corporation
10.20	Effective Quality Assurance Systematic Quality Assurance Process Key elements of Quality Assurance Process Factors in Drug Quality Assurance Dr. Saffari Abbas, Technical Officer, World Health Organization
11.00	Break
11.20	Analytical Method Validation Principle of Validation  Methods of Analysis Development of Protocol Requirements of Compendial Methods Dr. Saffari Abbas, Technical Officer, World Health Organization
12.00	Validation of Computer Systems  Impact on your ability to meet requirements Accuracy, reliability, integrity, availability, and authenticity of required records Affects on product quality and safety, and record integrity Equipment qualification Monitoring process performance Philip Lofty, Vice President, Business Development  Pharmaceutical Services Corporation
12.40	Lunch break
14.00	Corrective& Preventative Action (CAPA) Latest Expectations Non-conformances CAPA Systems Root cause analysis  Safwa Al Mousa, Quality Assurance Manager, Jordan Pharmaceutical Manufactoring Co
14.40	Inspections Inspection Planning Education and Training Trade Secrets and Confidential Information Out of Specification Do’s and Don’t’s Jamie Jamshidi, President, Pharmaceutical Quality Control Consulting Inc.
15.20	Break
15.40	Process Validation- Current and Future  Review current U.S./International Regulatory Guidelines and Industry Standards  Discuss Evolving Expectations for Process Validation Characteristics of a Sucessful Validation Provide Extensive Reference List Supporting Approach to Process Validation Benchmarking: Current Practice and Future Expectations as Related by Industry Practitioners Paul Pluta PhD, Director Quality/Technical, Chicago Control Systems Inc.
16.20	Technical Writing For Pharmaceutical and Biotech Industries Effective Standard Operating Procedures Good Document Practice (GDP)  Other Process Documents Ahed Ghanem, Manager Healthcare and Life Sciences, PriceWaterhouseCoopers
17.00	Close
Invited Faculty
Paul Pluta PhD, Director Quality/Technical, Chicago Control Systems Inc. Dr. Saffari Abbas, Technical Officer, World Health Organization Safwa Al Mousa, Quality Assurance Manager, Jordan Pharmaceutical Manufactoring Co Philip Lofty, Vice President, Business Development  Pharmaceutical Services Corporation Ahed Ghanem, Manager Healthcare and Life Sciences, PriceWaterhouseCoopers Jamie Jamshidi, President, Pharmaceutical Quality Control Consulting Inc.
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