FALLS CHURCH, Va., April 3, 2019 /PRNewswire-PRWeb/ -- Ensuring the Quality Connection with Your CMO via Risk Management **An Interactive Workshop Presented by FDAnews and ValSource** June 26-27, 2019 • Raleigh, NC
https://www.fdanews.com/cmo
Contract manufacturing organizations (CMOs) are a two-edged sword, boosting productivity without capital investment...or landing in a costly mess of trouble.
Everything depends on how one sets up and then manages the relationship.
And that's where we come in.
FDAnews has teamed up with ValSource, a leading management consultancy to life science manufacturers, to guide one to more productive, profitable and hassle-free relationships with CMOs. Attendees will find approaches that can be mutually beneficial.
The secret? A quality systems-based relationship with CMOs. Over the course of two highly interactive days of presentations and discussions, case studies, practical risk-based thinking activities with experienced instructors (who have worked on both sides of the contract giver and acceptor equation) attendees discover:
New to CMOs? Unhappy with things as they are? Maybe a fresh look at relationships that wither without constant attention is needed. Whatever the situation, this conference helps shape a leaner, more effective and profitable manufacturing situation.
Meet Workshop Leader: Hal Baseman is a Principal and COO of ConcordiaValSource and ValSource LLC boasting 30+ years' experience in drug, biopharma and device operations, validation and compliance. Prior experience includes executive and technical positions at several sterile-product manufacturing and consulting firms. He is a member of the PDA Board of Directors and Executive Committee, Co-Chair of the PDA Science Advisory Board, Co-Leader of the PDA Process Validation Interest Group, and a longtime member of the PDA Training Research Institute faculty.
Who Will Benefit: FDA-regulated health science companies across the board will find value in this two-day workshop, especially individuals with the following responsibilities:
Tuition: Early Bird Pricing: $1,597 (available until May 29, 2019) Regular Pricing: $1,797 (after May 29, 2019) Significant team discounts are available.
Easy Ways to Register: Online: https://www.fdanews.com/ By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
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Contract manufacturing organizations (CMOs) are a two-edged sword, boosting productivity without capital investment...or landing in a costly mess of trouble.
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Everything depends on how one sets up and then manages the relationship.
And that's where we come in.
FDAnews has teamed up with ValSource, a leading management consultancy to life science manufacturers, to guide one to more productive, profitable and hassle-free relationships with CMOs. Attendees will find approaches that can be mutually beneficial.
The secret? A quality systems-based relationship with CMOs. Over the course of two highly interactive days of presentations and discussions, case studies, practical risk-based thinking activities with experienced instructors (who have worked on both sides of the contract giver and acceptor equation) attendees discover:
- What to include in quality agreements: 'Must have' vs. 'nice to have'
- Working with a CMO using a hazard identification tool (HIT)
- Regulatory citations: Who is responsible — you, or the CMO?
- Monitoring and auditing your CMOs
- Team-building: Participation from the owners' organizations and CMOs (plant-in- plant concepts)
- Joint effective and efficient deviation investigation techniques
- Creating a checklist: Key items to consider when working with a CMO
- Avoiding and resolving conflicts between client company ("contract giver") and CMO ("contract acceptor")
- Communication information to comply with process validation and health authority expectations
New to CMOs? Unhappy with things as they are? Maybe a fresh look at relationships that wither without constant attention is needed. Whatever the situation, this conference helps shape a leaner, more effective and profitable manufacturing situation.
Meet Workshop Leader: Hal Baseman is a Principal and COO of ConcordiaValSource and ValSource LLC boasting 30+ years' experience in drug, biopharma and device operations, validation and compliance. Prior experience includes executive and technical positions at several sterile-product manufacturing and consulting firms. He is a member of the PDA Board of Directors and Executive Committee, Co-Chair of the PDA Science Advisory Board, Co-Leader of the PDA Process Validation Interest Group, and a longtime member of the PDA Training Research Institute faculty.
Who Will Benefit: FDA-regulated health science companies across the board will find value in this two-day workshop, especially individuals with the following responsibilities:
- Quality team
- Product Development
- Business Development
- Procurement
- Technical Services,
- CMO Professionals
Tuition: Early Bird Pricing: $1,597 (available until May 29, 2019) Regular Pricing: $1,797 (after May 29, 2019) Significant team discounts are available.
Easy Ways to Register: Online: https://www.fdanews.com/ By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
