All John Robinson compliance Events (69)

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

July 8, 2014 from 10am to 11:30am – Online Event Overview: Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing a… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
HACCP Validation and Verification

July 8, 2014 from 10am to 11am – Online Event Overview: HACCP elements of the Codex Alimentarius required by GFSI auditing schemes. The process by which the HACCP program is tested.HACCP validation and verification is an often neglected area of… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

Understanding and Preparing for FDA's on-going Part 11 Inspection Program

July 3, 2014 from 10am to 11:15am – Online Event Overview: FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 12 months FDA issued more than 10 warning letters with citations Part 11 vi… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
2-day In-person Seminar on The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures) at Singapore

July 3, 2014 at 9am to July 4, 2014 at 6pm – Mandarin Orchard Singapore Overview: This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, and efficacy and/or data integrity. Key components of documentation… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

Meet FDA Expectations for a Tougher Supplier Audit Program

July 2, 2014 from 10am to 11:30am – Online Event Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

2-day In-person Seminar on Applied Statistics for QA, QC, Manufacturing, and Design Control at Atlantic City NJ

June 26, 2014 from 9am to 6pm – WILL BE ANNOUNCED SOON Overview: The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The fl… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

2-day In-person seminar on Medical Device Software Risk Management and Assurance Case at Boston, MA

June 19, 2014 at 9am to June 20, 2014 at 6pm – Courtyard Boston Logan Airport Overview: Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

2-day In-person Seminar on FDA's and the U.S. Customs Border Patrol's Import and Export Control Program at Washington, DC

June 12, 2014 at 9am to June 13, 2014 at 6pm – WILL BE ANNOUNCED SOON Overview: FDA's and the Customs and Border Patrol Service (CBP) has become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Fi… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

2-day In-person Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems at Mumbai

June 5, 2014 at 9am to June 6, 2014 at 6pm – The LaLiT Mumbai The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 a… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
2-day In-person Seminar on Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions at Minneapolis

June 5, 2014 at 9am to June 6, 2014 at 6pm – WILL BE ANNOUNCED SOON Overview: FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in t… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

John Robinson's Event Types

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