SOPs for Virtual Companies - What You Need and What You Don't

Arvilla Trag Instructor:
Arvilla Trag 
60 Minutes
Webinar ID: 501734

More Trainings by this Expert

Price Details
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


Many virtual companies incorrectly think they don't need SOPs or GMP training.

The rationale is often "we aren't actually doing the manufacturing, so we don't need GMP training", and "we'll write SOPs when the product is approved, we're too busy now". Untrained and inexperienced personnel are allowed to perform GMP-related activities (such as executed batch record review, or approval of specifications) oblivious to the potential consequences of doing it without documented training and/or written procedures.

Even very small / virtual companies need SOPs and GMP training. 21 CFR 211.25(a) [Personnel qualifications] reads "Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions"

Unlike a CDMO, the virtual / small company is likely to need only a couple dozen written procedures for CMC. (Nonclinical and clinical SOPs are outside the scope of this webinar but are also needed.) The goal is to keep the SOPs as simple as possible, to incorporate multiple topics when feasible (such as types of training and training documentation), and to make sure everyone in the company understands how important this is. The use of flow diagrams for SOPs is strongly encouraged, as they facilitate training and provide a snapshot of what should be done without automatically requiring the tedium of pulling out the SOP itself.

This webinar will discuss what SOPs and training are really needed and what are not.

Why you should Attend: Anyone who is involved in GMP decision-making or is signing GMP-related documents needs to understand SOPs and have GMP training. You will learn how to be in compliance through written procedures, who needs GMP training (and who does not). You will also learn how written procedures can protect you and your IP.

Areas Covered in the Session:

  • Written procedures required by regulations
  • Written procedures mentioned in guidance documents
  • Written procedures that are just plain good ideas
  • How to write simple, clear SOPs for the above
  • Who in your company needs GMP training and why
  • How much is enough GMP training

Who Will Benefit:
  • Senior and Middle Management
  • Acting Quality Unit
  • Anyone with Signature Authority

Speaker Profile
Arvilla Trag, RAC is a CMC Compliance and Regulatory professional with over 30 years of experience in biotechnology CMC and GxP compliance. Experienced in all phases and types of CMC-related regulatory submissions, strategy and meetings, from IND/IMPD to BLA. She has particular expertise in CTD Modules 3 and 2.3, comparability strategies and reports, meeting and pre-meeting packages, CMC amendments, CMC regulatory strategy, responding to FDA questions/observations, and due diligence. Product-type experience includes monoclonal antibodies, vaccines, LVP biologics, recombinant proteins, ADCs and some cell therapy. Meeting experience with FDA includes face-to-face and teleconferences for dozens of INDs, BLA submissions, Breakthrough Designation, and CMC amendments.

Ms. Trag also provides all aspects of CMC QA and has performed >275 compliance audits including due diligence, vendor qualification, and for-cause. She offers GMP training at all levels, from annual refresher to Executive Management GMP training. She provides development or remediation of Quality Management Systems, including SOPs, deviation reports, root cause analysis and CAPA. Ms. Trag holds a BA in Biology/Chemistry from the College of St. Rose (magna cum laude) and has been Regulatory Affairs Certified since 1994.

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