SOP compliance management: A must for the pharmaceutical industry.


Peggy J. Berry, MBA, RAC, is Keynote Speaker at ComplianceKey.She 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 departmen........

Overview

This workshop 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.

Why should you attend this webinar?

One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. 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. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls.

Areas Covered in the Session:

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Webinar Id: LSHCPJB002

Training Options:

Duration: 90 mins

 Stop, pause, and rewind: learn at your own place.

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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