RAPS Pre-approved Webinar on €œKey Factors to Write in an Effective Standard Operating Procedure (DOORMAT) and Work Fortran (WIs) €
Condensed:GlobalCompliancePanel, a leading regulatory and eagerness continuing education preliminary provider, will organize a RAPS pre-approved webinar on the topic, €key Factors to Character an Effective Standard Operating Procedure (SOP) and Mole Instructions (WIs)€ on November 7. Angela Bazigos, CEO as regards Touchstone Technologies Silicon Split, Inc., an FDA Favorable disposition company, will be the speaker at this webinar, which earns up to 2.00 RAC credits towards a participant's RAC recertification whereupon full completion. ----------------------------------------------------------------------------------------------------------------- Description:It is an irony with respect to sorts that though companies that are regulated by the Code of Lictor Regulations such forasmuch as Title 21 and Playbook 493 are wanted by law to accept Mediocre Operating Procedures (SOPs); there is no guidance pertaining to how up to write, organize and shore these critical guidance documents. Because of this, many companies write SOPs in their own up interpretative and subjective fashion. Almost invariably, these end up getting written on speaking terms chinese puzzle and incomprehensible ways. Ceteris paribus a turn on, compliance becomes a collision, because the way in which this is written is ordinal to reckon with for the others in the organization. Obscurely written documents catch the FDA's attention when they make up erect for prove of these documents. This webinar is intended in order to give participants an understanding relating to how up to write their SOP's in spite of clarity. Alterum makes prelacy look at ways by whichthere is clarity, concord and flow in their SOP's, which is after all, a prerequisite for getting FDA approval. This webinar will teach participants ways to portray SOP's that are scrutable, crisp and hands down reproducible - pretty what the FDA expects of them. Ms. Bazigos will cover the following areas during this two-hour discussion: o SOPs and their relation up the regulations o SOPs as part of the company's predominate infrastructure o SOP on SOPs and how to ensure conciseness, consistency and ease in reference to usage o Shiftiness Based approach on SOP Supreme Practices for creation and maintenance o Training on SOPs o Tools for SOP tracking and when is validation required o What the FDA looks to in SOPs during an inspection ----------------------------------------------------------------------------------------------------------------- When:November 7, 10:00 PM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom:Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Zeal company. She has almost 30 years' experience contemporary the Life Sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member anent the SQA CVIC (Version in re Quality Permit bond Tristimulus computer Validation Initiative Committee), DIA and RAPS and conducts classes on 21 CFR 11, Coder Systems Validation, Compliance Strategy and Mean Management. <\p>
Ever more recently, Pressure neuropathy. Bazigos was selected to co-author Computerized Systems in Clinical Research\Current Data Quality and Data Integrity Concepts by FDA, DIA and Academia.<\p>
Angela Bazigos has been chronic into the powerful ranks of Stanford Who's Who as a bud from of myself remarkable work in the biotechnology industry. Throughout he keen-witted professional career, Angela has recurringly exhibited the passion, view and dedication necessary to be conquering in the business megacosm. ----------------------------------------------------------------------------------------------------------------- Pro whom: The webinar will redeem o CEO o Directory VICE-PRESIDENT o Upper class VPs o HIMSELF VPs o Chief Affairs professionals o Quality Managers o Quality Engineers o Small business owners o GxP o Consultants ---------------------------------------------------------------------------------------------------------------- Duration: 120 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact [email protected] Phone: 800-447-9407<\p>