Instructor Profile: Peggy Berry - ComplianceOnline Quality & Compliance Portal

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Peggy Berry
Founder, Synergy Consulting LLC

Peggy J. Berry, MBA, RAC, is the president and 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 Dey Pharma (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).

Trainings by Expert

Packaging and Labeling for Commercial and Clinical Products
Category: Drugs and Chemicals (Pharma) , Packaging and Labeling , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Drugs Regulations , Risk Management & Controls , All FDA Regulated Functions , Manufacturing Quality , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Preparing Stability Protocols for Development and Commercial Products
Category: Drugs and Chemicals (Pharma) , All FDA Regulated Industry , Drug and Device Approvals , Quality and Safety , Supply Chain and Manufacturing , Drug Development , Drugs Regulations , Risk Management & Controls , All FDA Regulated Functions , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

Preparation for GMP Inspections by Regulatory Agencies
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , Quality and Safety , Supply Chain and Manufacturing , Quality & Safety , Drugs Regulations , Biotech Regulations , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , All FDA Reg. based Audit , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Setting Specifications for Drug Substances and Drug Products
Category: Drugs and Chemicals (Pharma) , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , Drugs Regulations , Life sciences QA/QC , Supply chain & Procurement , Regulations & Guidances , Regulatory Affairs , Common FDA Regulations , QA/QC

Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)
Category: Drugs and Chemicals (Pharma) , All FDA Regulated Industry , GXP Pharmaceutical , Drug and Device Approvals , Quality and Safety , Supply Chain and Manufacturing , Drug Development , Drugs Regulations , Life sciences QA/QC , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Selection and Management of Contract Vendors
Category: Drugs and Chemicals (Pharma) , Clinical Research , Risk Management , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Crisis Management , Supply Chain and Manufacturing , Drugs Regulations , Clinical Trial Regulations , Life sciences QA/QC , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

Providing DMFs in eCTD format
Category: Drugs and Chemicals (Pharma) , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , Documentation and IT , Quality and Safety , Supply Chain and Manufacturing , Quality & Safety , Biologics and Biosimilars , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies
Category: Drugs and Chemicals (Pharma) , Clinical Research , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , Trial Design and Management , Drugs Regulations , Clinical Trial Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

ICH Q11 - API Manufacturing
Category: Drugs and Chemicals (Pharma) , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , Drug Development , Drugs Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?
Category: Drugs and Chemicals (Pharma) , Clinical Research , GCP & Other Best Practices , Trial Design and Management , Clinical Trial Regulations , Audit & Inspection-Role , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

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