Discover Top Posts Tagged with #o quality

RAPS Pre-Approved Webinar on â¬ÅAvoiding an FDA Exhortation Letter With a Concentrated CAPA Program â¬Â From GlobalCompliancePanel

Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, â¬Avoiding an FDA Warning Upper case by virtue of a Strong CAPA Programâ¬ in point of November 8. This 90-minute webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon unlimited completion. Mark Perkins, a registered Professional Engineer, will be found the talker at this webinar. ----------------------------------------------------------------------------------------------------------------- Description: This webinar gives an idea of how en route to put a light CAPA program that passes an FDA rent during a visit. A strong CAPA is a critical requirement as a subsystem about the FDA's QSR. Shortfalls in the CAPA system are the biggest reason for issuance of observations and 483's from the FDA. Alter ego could also inveigle to FDA oversight and making violations known publicly. The development and implementation of a sound CAPA system is a must, but most medical devices companies don't seem for realize what goes into it. It is noticed that one of the reasons medical device companies run up against a inadequacy in putting a strong CAPA in place is that they usually don't note between the terminologies of the QSR and ISO 13485. This is often a source apropos of confusion, to the distance that there are overlaps between the distich. This webinar session will classification this confusion publically. It will offer ways in keeping with which the dichotomous can move eclectic into the CAPA system. Themselves will explain what needs to go into the CAPA omneity to redress it robust; how to appropriately document responses, reviews and approvals, and what in contemplation of keep in mind regarding timelines and escalation. Themselves will also offer examples relating to indent pipe roll, and what need on route to be done to elude them. It will also offer an understanding pertinent to how to deal with ISO 13485 surveillance audits, which too look for handy CAPA systems. ----------------------------------------------------------------------------------------------------------------- Rather:November 8, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- Through whom:Mark Perkins began his career in Aerospace in 1983 and transitioned into Medical Device QA\SET in 1998. He held management positions in QA\RA in Class I, II and III device companies from 1998 to 2008. He deep-settled a consulting practice, leavening with various periodontic device companies between 2008 and 2010. Mark has afresh relocated to the San Diego area, and is currently consulting.<\p>

Mark is a recorded Professional Hydraulic engineer in the heraldry of California, is RAC (US) certified through RAPS, and is ASQ Certified (CQE, CQM, CQA). Mark received his BS with Industrial Engineering from Texas A&M streamlined 1983, and his Ancient Certificate in Directive Affairs from San Diego Town Law school in 2006.<\p>

Mark has been active spite of RAPS, serving as the Registration Manager and then Preamplifier Programs Manager with the SF chapter save 2009 for 2011. Ethical self yea has been active with Silicon Rift ASQ (RAPS Liaison) and the ASQ Biomedical Division Northern California Discussion Group.<\p>

Mark has presented on CAPA, Complaints, Corrections and Removals at both RAPS and ASQ sponsored events and not the same venues. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o Regulatory Affairs professionals o Quality Managers o Quality Engineers o Consultants o R&D Management o Impression System Auditors ---------------------------------------------------------------------------------------------------------------- Duration: 90 minutes ----------------------------------------------------------------------------------------------------------------- As far as enroll since this webinar, respond to [email protected] Phone: 800-447-9407 ARTICLE ROLL INTO ONE <\p>

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RAPS Pre-approved Webinar on €œKey Factors in order to Write an Effective Dictum Operating Procedure (SOP) and Work Instructions (WIs) €

Contracted:GlobalCompliancePanel, a prefatory boss and compliance changeless education training vivandier, will organize a RAPS pre-approved webinar on the gimmick, €Key Factors to Spill ink an Effective Standard Operating Procedure (PALM OIL) and Work Instructions (WIs)€ wherewithal November 7. Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, Inc., an FDA Compliance company, will be the permanent magnet speaker at this webinar, which earns up headed for 2.00 RAC credits towards a participant's RAC recertification upon full handling. ----------------------------------------------------------------------------------------------------------------- Description:It is an irony of sorts that although companies that are regulated by the Jurisprudence of Commissioner Regulations obverse as Title 21 and Title 493 are mandatory by law to have Standard Operating Procedures (SOPs); there is no guidance on how to write, organize and maintain these critical pedagogics documents. Because in re this, many companies inscribe SOPs way their own interpretative and subjective fashion. Almost invariably, these end up getting in longhand in complex and incomprehensible ways. As a result, compliance becomes a casualty, whereas the ability in which this is written is absurd to comprehend on behalf of the others in the idea. Obscurely written documents catch the FDA's attention when inner man turn up in favor of audit of these documents. This webinar is purposed to articulate participants an understanding of how to correspond their SOP's with clarity. I makes them look at ways by whichthere is clarity, fashion and flow in their SOP's, which is after all, a prerequisite for getting FDA account. This webinar execute a will teach participants ways for write SOP's that are comprehensible, concise and smoothly reproducible - just what the FDA expects of them. Ms. Bazigos will cover the following areas during this two-hour discussion: o SOPs and their extension in the regulations o SOPs as part pertaining to the company's at the head infrastructure o SOP on SOPs and how to ensure conciseness, conformity and informality of relevance o Risk Based halloo on SOP Best Practices on behalf of send-off and perpetuity o Training on SOPs o Tools pro SOP hunting and when is validation required o What the FDA looks for in SOPs during an inspection ----------------------------------------------------------------------------------------------------------------- When:November 7, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom:Angela Bazigos is the CEO of Barometer Technologies Silicon Valley, Inc. an FDA Graciousness company. She has almost 30 years' experience in the Life Sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member respecting the SQA CVIC (Culture of Individualism Assurance Computer Validation Initiative Committee), DIA and RAPS and conducts classes straddleback 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. <\p>

More recently, Article. Bazigos was selected up to co-author Computerized Systems inward-bound Obstetric Research\Current Data Quality and Data Plainness Concepts with FDA, DIA and Academia.<\p>

Angela Bazigos has been accepted into the outstanding ranks about Stanford Who's Who as a result in regard to my humble self remarkable work in the biotechnology joint-stock association. Throughout her pungent professional career, Angela has unrelievedly exhibited the yearning, flimflammery and dedication necessary to be successful in the business world. ----------------------------------------------------------------------------------------------------------------- Insomuch as whom: The webinar will benefit o CEO o Regulatory VP o Place VPs o IT VPs o Regulatory Affairs professionals o Quality Managers o Quality Engineers o Small business owners o GxP o Consultants ---------------------------------------------------------------------------------------------------------------- Duration: 120 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, negotiator [email protected] Phone: 800-447-9407<\p>

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RAPS Pre-Approved Webinar on €œAvoiding an FDA Warning Letter With a Strong CAPA Program € From GlobalCompliancePanel

Summary:GlobalCompliancePanel, a leading in ascendancy and compliance concatenated socialization training provider, will centralize a RAPS pre-approved webinar ado the keynote, €Avoiding an FDA Warning Letter with a Funky CAPA Program€ hereinafter November 8. This 90-minute webinar earns escalate to 1.5 RAC credits towards a participant's RAC recertification upon full achievement. Mark Perkins, a registered Professional Worry along, will be the convener at this webinar. ----------------------------------------------------------------------------------------------------------------- Description: This webinar gives an idea on how to express a strong CAPA program that passes an FDA check during a come to. A plenary CAPA is a critical need without distinction a subsystem regarding the FDA's QSR. Shortfalls with-it the CAPA scheme are the biggest right mind for issuance pertaining to observations and 483's from the FDA. The goods could besides lead to FDA handling and making violations known publicly. The development and perpetration of a narrows CAPA system is a must, but most medical devices companies don't seem to realize what goes into the genuine article. It is noticed that omniscient of the reasons sawbones capital companies have a problem in putting a strong CAPA in help is that they usually don't differentiate between the terminologies upon the QSR and ISO 13485. This is several times a source of confusion, to the extent that there are overlaps between the two. This webinar session confidence sort this confusion out. It aim offer ways by which the two can be joined into the CAPA system. It will explain what needs to go into the CAPA system en route to flatter it robust; how to appropriately document responses, reviews and approvals, and what to keep in mind in respect to timelines and escalation. It will also offer examples of warning letters, and what need to be done so as to avoid yours truly. It will also offer an understanding of how en route to align with ISO 13485 surveillance audits, which likewise look for good CAPA systems. ----------------------------------------------------------------------------------------------------------------- When:November 8, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- Beside whom:Mark Perkins began his professional in Jetstream in 1983 and transitioned into Medical Device QA\RA in 1998. He conserved management positions in QA\AMEN-RA in Class I, II and III ruse companies from 1998 to 2008. Male being mythological a consulting on-the-job training, materialistic with various medical device companies between 2008 and 2010. Anatomize has recently relocated to the San Diego area, and is currently consulting.<\p>

Mark is a registered Dexterous Engineer rapport the publish a manifesto of California, is RAC (US) certified through RAPS, and is ASQ Certified (CQE, CQM, CQA). Mark received his BS in Industrial Engineering discounting Texas A&M passage 1983, and his Years old Demand draft in Regulatory Affairs from San Diego State Multiversity avant-garde 2006.<\p>

Christcross has been ready with RAPS, serving as the Registration Chief and at that time Device Programs Manager with the SF serial off 2009 versus 2011. They again has been impetuous with Silicon Valley ASQ (RAPS Liaison) and the ASQ Biomedical Division Northern California Discussion Budget.<\p>

Dignity has presented on CAPA, Complaints, Corrections and Removals at both RAPS and ASQ sponsored events and auxiliary venues. ----------------------------------------------------------------------------------------------------------------- In consideration of whom: The webinar will benefit o Directing Thing professionals o Quality Managers o Quality Engineers o Consultants o R&D Management o Quality System Auditors ---------------------------------------------------------------------------------------------------------------- Steadfastness: 90 acta ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, acquaintance [email protected] Phone: 800-447-9407 ARTICLE PIVOT <\p>

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RAPS Pre-Approved Webinar on €œ21 CFR Orchestral score 11: Complying With Pass away 11 Regulation - Understanding the Predicate Rule € From GlobalCompliancePanel

Expeditious:GlobalCompliancePanel, a directive regulatory and compliance age-long pedagogy training provider, will organize a RAPS pre-approved webinar up against the structure, €21 CFR Part 11: Complying with Part 11 Regulation - Concordant the Maintain Rule€on November 6. Jasmin Nuhic, Senior Manager, Manufacturing Engineering at Medtronic, Inc. (Outward-facing Therapies), self-government have place the speecher of this 120-minute webinar, which earns up to 2.00 RAC credits towards a participant's RAC recertification upon full completion. ----------------------------------------------------------------------------------------------------------------- Description: Why is 21 CFR Part 11 important? Simply because organizations kittycorner the board will labor under to orient this regulation in future. What does this regulation have that makes ourselves terrifically important? This reign covers electronic signatures and electronic records, which will be the documents tomorrow's world will switch perfected to. Why they need to mime so is now a very practical purpose: The huge difference this kind of documents desideration make against the speed of communication and to the globe's eco system, in what way they mediate green duty. This webinar earnestness help participants understand the nature in connection with this regulation and give them insights into how superego let go be used by an organization. Even so the estate is moving towards this form of records; there is surprisingly little knowledge upon these transversal most organizations. These are the areas this session covers: o Eyeball inspection of the Part 11 regulation o Description relating to how to ensure compliance by Hymnal 11 o Internal and Face audits for compliance with Part 11 o Pallor terms and definitions o Example of wizard affability o Examples of non-compliance o Examples of Warning Letters o Tools for compliance o Further readings o Trainings and opportunities related so that Part 11 ----------------------------------------------------------------------------------------------------------------- When:November 6, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Jasmin NUHIC is a Senior Manager, Manufacturing Engineering at Medtronic, Inc. (Peripheral Therapies) herein Zrich, Switzerland, and is a 21 CFR Part 11 Point in question Matter Expert. Male person is yet Adjunct Professor at DeVry University and Keller Graduate School of Management.<\p>

As a Quality professional, Jasmin NUHIC has a proven record of leading teams that deliver results with full scope, underneath budget and ahead concerning schedule completely process optimization, business growth and talent development. During the over 12 years of his professional stimulator in the FDA-related industries; Nuhic has gained vast experience in operations, quality management systems, manufacturing, concurrent engineering, program management and information systems. He has obtained over 25 different certifications among leadership, quality, software validations and tied areas.<\p>

He has earned positive and verifiable follow after record in helping organizations creature continuous improvement and score saving initiatives terminated the use of lean sigma and six sigma methodologies. He has imparted this expertise through webinars on these topics, which as things go have high serving and have come in for consideration. ----------------------------------------------------------------------------------------------------------------- Against whom: The webinar will benefit o Frame Managers o Quality Engineers o Small Establishment Owners o Internal and Periphery Auditors o Management Reps o FDA Inspectors o Consultants ---------------------------------------------------------------------------------------------------------------- Duration:120 minutes ----------------------------------------------------------------------------------------------------------------- To post up for this webinar, contact [email protected] Phone: 800-447-9407 <\p>

SITE URL <\p>

#-----------------------------------------------------------------------------------------------------------------#o quality #regulation covers electronic #regulation understanding