Biotech China 2014
5th Annual Medical Device and Pharmaceutical Manufacturing and Quality Assurance Forum

San Antonio
TX , USA
http://www.q1productions.com/conferencepost/4th-annual-medical-device-pharmaceutical-manufacturing-quality-assurance-forum/?utm_source=eventcalendar&utm_medium=socialmarketing&utm_campaign=F8019#.Ufj-E6yCBN8
5th Annual Medical Device and Pharmaceutical Manufacturing and Quality Assurance Forum 
Q1 Productions 
http://www.q1productions.com/conferencepost/4th-annual-medical-device-pharmaceutical-manufacturing-quality-assurance-forum/?utm_source=eventcalendar&utm_medium=socialmarketing&utm_campaign=F8019#.Ufj-E6yCBN8
San Antonio
TX 
USA

Schedule of Presentations:

Thursday, October 10, 2013
06:00:00 New Presentation
07:30:00 REGISTRATION & CONTINENTAL BREAKFAST
08:25:00 CHAIRPERSON’S OPENING REMARKS CROSS INDUSTRY SESSIONS
08:30:00 KEYNOTE PANEL: IMPLEMENTING COST REDUCTION STRATEGIES WITHOUT REDUCING OVERALL QUALITY STANDARDS
09:15:00 GENENTECH CASE STUDY: VARIABILITY REDUCTION STRATEGIES TO INCREASE END GAME THROUGHPUT
10:00:00 COFFEE & NETWORKING BREAK
11:00:00 EVALUATING THE EFFECT OF DESIGN FOR MANUFACTURABILITY (DFM) PLANS ON MANUFACTURING AND QUALITY PROCESSES David Amor
11:00:00 MULTI-THERAPUETIC PERSPECTIVE PANEL DISCUSSION: DEBATING THE COMPLEXITIES OF MANUFACTURING WITHIN TODAY’S EVER-EVOLVING ENVIRONMENT
11:45:00 UTILIZATION OF HUMAN FACTORS ENGINEERING (HFE) PRACTICES TO REDUCE POTENTIAL ADVERSE EVENTS
11:45:00 EXTERNAL MANUFACTURING: ESTABLISHING AND MAINTAINING PRODUCTIVE CMO PARTNERSHIPS
12:30:00 NETWORKING BREAK & LUNCHEON FOR ALL PARTICIPANTS
14:00:00 LIVE WEBINAR: APPLICATION OF UNIQUE DEVICE IDENTIFIER (UDI) PROCESSES TO ENSURE REGULATORY COMPLIANCE
14:00:00 SUPPLIER RISK MANAGEMENT: CREATION AND IMPLEMENTATION OF VENDOR ASSESSMENT MATRICES
14:45:00 MEDICAL DEVICE PACKAGING INTEGRITY AND VALIDATION STRATEGIES
14:45:00 OVERCOMING CHALLENGES ASSOCIATED WITH THE IMPLEMENTATION OF SINGLE-USE MANUFACTURING SYSTEMS
15:30:00 COFFEE & NETWORKING BREAK
15:30:00 COFFEE & NETWORKING BREAK
16:30:00 EXTERNAL MANUFACTURING: QUALIFICATION AND EVALUATION CONSIDERATIONS FOR CMO PARTNERSHIPS
16:30:00 EXECUTING STREAMLINED TECHNOLOGY TRANSFER THROUGHOUT PHARMACEUTICAL MANUFACTURING FACILITIES
17:20:00 PANEL DISCUSSION: OPERATIONAL AND REGULATORY CONSIDERATIONS FOR INTERNATIONAL MANUFACTURING
18:05:00 NETWORKING MEETING & COCKTAIL RECEPTION FOR ALL FORUM PARTICIPANTS
19:05:00 CONCLUSION OF DAY ONE FORUM EVENTS
Friday, October 11, 2013
07:30:00 CONTINENTAL BREAKFAST & NETWORKING OPPORTUNITY
07:55:00 CHAIRPERSON’S OPENING REMARKS CROSS INDUSTRY SESSION
08:00:00 PANEL DISCUSSION: 483 INSPECTION OBSERVATION RESPONSE MANAGEMENT BEST PRACTICES
08:50:00 INSTITUTING RISK MANAGEMENT PROCEDURES INTO MANUFACTURING OPERATIONS TO PREVENT QUALITY DISCREPANCIES
08:50:00 SUPPLIER RISK MANAGEMENT: QUALIFICATION AND VALIDATION OF SUPPLIER PARTNERS AND MATERIAL VENDORS
09:35:00 COFFEE & NETWORKING BREAK
09:35:00 COFFEE & NETWORKING BREAK
10:35:00 APPLICATION OF EXHAUSTIVE VALIDATION AND RE-VALIDATION STRATEGIES TO SUSTAIN CONTINUED PRODUCT QUALITY COMPLIANCE
10:35:00 INTERACTIVE WORKSHOP: ENGAGING IN EXTENSIVE CAPA PROGRAMS TO ENSURE OVERALL PRODUCT QUALITY & EFFICACY
12:00:00 NETWORKING BREAK & LUNCHEON FOR ALL PARTICIPANTS
13:00:00 ENHANCING REGULATORY INSPECTION READINESS LEVELS WITH THE EMPLOYMENT OF INTERNAL QUALITY AUDITS
13:00:00 EFFECTIVE INTERNAL AUDITING PRACTICES TO ENSURE FACILITY’S PREPAREDNESS FOR REGULATORY INSPECTIONS
13:45:00 DESIGN AND EXECUTION OF CHANGE CONTROL MANAGEMENT PROCESS WITHIN MANUFACTURING OPERATIONS
13:45:00 OUTLINING THE SIGNIFICANCE OF RISK MITIGATION STRATEGIES THROUGHOUT THE PRODUCT LIFECYCLE
14:30:00 COFFEE & NETWORKING BREAK
14:30:00 COFFEE & NETWORKING BREAK
15:00:00 DECODING THE IMPORTANCE OF COMPLIANT AND COMPREHENSIVE DESIGN TRANSFER PLANS
15:00:00 ADVANCEMENT AND ADOPTION OF QUALITY BY DESIGN PRINCIPLES WITHIN MANUFACTURING AND QUALITY PROCEDURES
15:45:00 INTERACTIVE WORKSHOP: INCREASING OVERALL QUALITY COMPLIANCE STANDARDS THROUGH COMPREHENSIVE TRAINING PROGRAMS
16:30:00 CLOSING REMARKS AND PROGRAM CONCLUSION
4th Annual Pharma R&D Asia Congress
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