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OVERVIEW
This webinar will review the current regulations, guidance documents for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labelling, and documentation requirements will also be reviewed and explored.
WHY SHOULD YOU ATTEND
Attend this webinar so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for your GMP documentation.
AREAS COVERED
- IND and NDA Content and Format for CMC Information
- Vendor Selection and Management for Outsourcing early Manufacturing
- Raw Material Selections and Considerations
- Required SOPs and Documentation
LEARNING OBJECTIVES
Learn the rules and regulations governing GMP Documentation. Also learn about the development and implementation of strategies for GMP documentation.
WHO WILL BENEFIT
- Directors
- Managers
- Supervisors in Regulatory Affairs
- Manufacturing
- Quality Assurance and Clinical Operations
SPEAKER
Years of Experience: 30+
Areas of Expertise: Drug Development, Regulatory Affairs and Project Management
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).
She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and DeyPharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).
In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).
View all trainings by this speaker
OVERVIEW
This webinar will review the current regulations, guidance documents for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labelling, and documentation requirements will also be reviewed and explored.
WHY SHOULD YOU ATTEND
Attend this webinar so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for your GMP documentation.
AREAS COVERED
- IND and NDA Content and Format for CMC Information
- Vendor Selection and Management for Outsourcing early Manufacturing
- Raw Material Selections and Considerations
- Required SOPs and Documentation
LEARNING OBJECTIVES
Learn the rules and regulations governing GMP Documentation. Also learn about the development and implementation of strategies for GMP documentation.
WHO WILL BENEFIT
- Directors
- Managers
- Supervisors in Regulatory Affairs
- Manufacturing
- Quality Assurance and Clinical Operations
SPEAKER
Years of Experience: 30+
Areas of Expertise: Drug Development, Regulatory Affairs and Project Management
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).
She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and DeyPharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).
In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).
View all trainings by this speaker
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