SOPs for Commercialization
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, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).
SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions, including sales, marketing, manufacturing, quality, and regulatory affairs. An absence of and non-adherence to SOPs are often cited in regulatory inspections as deficiencies. Poorly prepared SOPs or poor compliance with existing SOPs can compromise commercialization efforts, maintenance of an effective quality system, and may result in product recalls.
- Regulatory requirements for GCP SOPs
- Regulatory requirements for GMP SOPs
- Regulatory requirements for advertising, promotion, and Sunshine Act compliance in sales and marketing
- Legal requirements for SOP creation and maintenance
- Types of SOPs
- Formats and essential components of SOPs
- How to effectively write an SOP to ensure compliance
- SOP training and implementation
- Documenting deviations from and changes to SOPs
Who Should Attend
- Regulatory operations
- Clinical operations
- Project managers
- Compliance officers
Why Should Attend
This webinar will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.