Quality Control, Safety & Security

Listings
  • Quality Management in Pharmaceutical Industry: GMP Compliance 2018

    Quality Management in Pharmaceutical Industry: GMP Compliance 2018

    Quality Control, Safety & Security Seattle (Washington) March 6, 2018 1.00 Dollar US$

    Overview: The Purpose of this Course is to Review ICH Q10, which is a Document developed by the 3 Countries Comprising ICH (Us, Eu, Japan). ICH Q10 is for the Development of a Pharmaceutical Quality System, In Conjunction with the Companion Documents...

  • Statistical Sampling Plans - Seminar 2018 Methods and Applications

    Statistical Sampling Plans - Seminar 2018 Methods and Applications

    Quality Control, Safety & Security Seattle (Washington) March 6, 2018 1.00 Dollar US$

    Overview: Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this rich field of techniques is not as prominent as it once had been....

  • When Conducting cGMP Regulatory Inspections 2018

    When Conducting cGMP Regulatory Inspections 2018

    Quality Control, Safety & Security Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA,...

  • What you Need to Know to Prepare FDA Inspection

    What you Need to Know to Prepare FDA Inspection

    Quality Control, Safety & Security Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently ...

  • What are the Tools required for Human Error Reduction

    What are the Tools required for Human Error Reduction

    Quality Control, Safety & Security Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues. Areas Covered in the Session: Bac...

  • Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Quality Control, Safety & Security Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, an...

  • cGMPs in the Quality Control Laboratory (Medical 2018)

    cGMPs in the Quality Control Laboratory (Medical 2018)

    Quality Control, Safety & Security Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and ...

  • Good Documentation Guideline (Chapter 1029 USP)

    Good Documentation Guideline (Chapter 1029 USP)

    Quality Control, Safety & Security Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system. Why should you Attend: GDP is part of GMP and if you know it by heart, it preve...

  • FDA New Draft Guidance on (Software) and Device Changes 510k

    FDA New Draft Guidance on (Software) and Device Changes 510k

    Quality Control, Safety & Security Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a) (3)) that is not subject to PM...

  • Record Keeping Best Practices [FDA and EMA] Documentation

    Record Keeping Best Practices [FDA and EMA] Documentation

    Quality Control, Safety & Security Fremont (California) September 12, 2018 150.00 Dollar US$

    Overview: Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses tha...

  • That your Supplier can meet all your Expectations

    That your Supplier can meet all your Expectations

    Quality Control, Safety & Security Fremont (California) September 12, 2018 150.00 Dollar US$

    Overview: These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit the operation. Why should you Atten...

  • Which are Compliant for Inspections for a [GXP Compliance]

    Which are Compliant for Inspections for a [GXP Compliance]

    Quality Control, Safety & Security Fremont (California) September 12, 2018 150.00 Dollar US$

    Overview: This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements. Why should you Attend: This webinar will assist you to prepare for inspection of SOPs, particularly...