CAPA

California Assemblymember Tom Lackey and Safety Advocates Oppose SB 930 - the Late-Night Bar Bill

Retrieved on: 
Friday, August 12, 2022 - 3:15pm

SACRAMENTO, Calif., Aug. 12, 2022 /PRNewswire/ -- Assemblymember Tom Lackey (R-Palmdale) and safety advocates from Alcohol Justice, and the California Alcohol Policy Alliance (CAPA) gathered at a Capitol press event Wednesday to oppose California SB 930. The "gut & amend" bill, authored by Senator Scott Wiener (D-San Francisco), and Assembly Member Mark Haney (D-San Francisco), is the 5th attempt since 2013 to disrupt the protections of California's statewide, uniform last call.

Key Points: 
  • SACRAMENTO, Calif., Aug. 12, 2022 /PRNewswire/ -- Assemblymember Tom Lackey (R-Palmdale) and safety advocates from Alcohol Justice ,and the California Alcohol Policy Alliance (CAPA) gathered at a Capitol press event Wednesday to oppose California SB 930.
  • "I do not know how legislators who vote yes will reconcile the loss of life," state Assemblymember Lackey.
  • "As a 28-year California Highway Patrol veteran, I have made over 40 death notifications to victims of impaired driving.
  • SB 930 would allow closing times for on-sale retailers to be extended from 2 a.m. to 4 a.m. as part of a dangerous "pilot program."

Assemblymember Tom Lackey Joins Health and Safety Advocates to Oppose SB 930 - the 4 a.m. Bar Bill

Retrieved on: 
Tuesday, August 9, 2022 - 6:25pm

If the bill becomes law, all surrounding communities of pilot project cities will be threatened by late night drinkers traveling drunk and fatigued into the early morning commute hours.

Key Points: 
  • If the bill becomes law, all surrounding communities of pilot project cities will be threatened by late night drinkers traveling drunk and fatigued into the early morning commute hours.
  • According to the Center for Disease Control (CDC), California currently suffers more annual alcohol-related harm than any other state: 11,000 alcohol-related deaths, $35 billion in total costs, $18.5 billion in state costs.
  • Opposition to SB 930 is growing statewide.
  • Last week, the Los Angeles City Council passed a resolution of opposition , and the powerful Los Angeles County Democratic Party (LACDP) came out against SB 930 in a letter dated June 27, 2022.

Los Angeles City Council Votes NO on SB 930 - the 4 a.m. Bar Bill, Sends Strong Message to Sacramento and Senator Wiener that Public Safety is more Important than Nightlife Revenue

Retrieved on: 
Saturday, August 6, 2022 - 3:35am

SB 930 would allow closing times for on-sale retailers to be extended from 2 a.m. to 4 a.m. as part of a dangerous "pilot program."

Key Points: 
  • SB 930 would allow closing times for on-sale retailers to be extended from 2 a.m. to 4 a.m. as part of a dangerous "pilot program."
  • The experiment would take place in 6 cities: San Francisco, Oakland, West Hollywood, Cathedral City, Coachella, and Palm Springs.
  • In Los Angeles, the powerful Los Angeles County Democratic Party (LACDP) came out against SB 930 in a letter made public before a City Hall opposition rally last week.
  • Alcohol Justice encourages the public to TAKE ACTION to STOP SB 930: Text JUSTICE to 313131 or visit: https://alcoholjustice.org/take-action/stop-sb-930-no-late-last-calls-in...

FDA Recalls Training Course: Understanding Recall Authority and Policy - Before You Start, and After You Finish Best Practices and Common Pitfalls (September 21-22, 2022) - ResearchAndMarkets.com

Retrieved on: 
Monday, August 1, 2022 - 12:18pm

The "FDA Recalls - Before You Start, and After You Finish - Best Practices and Common Pitfalls Training Course - 2 Day" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FDA Recalls - Before You Start, and After You Finish - Best Practices and Common Pitfalls Training Course - 2 Day" training has been added to ResearchAndMarkets.com's offering.
  • The knowledge you gain will sharpen your recall management decisions and strategy.
  • You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures.
  • Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls.

Los Angeles Rallies to STOP SB 930 - 4 a.m. Bar Bill in Southern California

Retrieved on: 
Friday, July 29, 2022 - 2:03am

LOS ANGELES, July 28, 2022 /PRNewswire/ -- Members of Los Angeles Drug & Alcohol Policy Alliance (L.A. DAPA), California Alcohol Policy Alliance (CAPA) and Alcohol Justice, along with Los Angeles City Councilmember Paul Koretz, demonstrated at a City Hall rally yesterday to oppose California SB 930. The "gut & amend" bill, authored by Senator Scott Wiener (D-San Francisco) and Assembly Member Mark Haney (D-San Francisco) is the 5th attempt since 2013 to disrupt the protections of California's statewide uniform last call.

Key Points: 
  • LOS ANGELES, July 28, 2022 /PRNewswire/ -- Members of Los Angeles Drug & Alcohol Policy Alliance (L.A. DAPA), California Alcohol Policy Alliance (CAPA) and Alcohol Justice , along with Los Angeles City Councilmember Paul Koretz , demonstrated at a City Hall rally yesterday to oppose California SB 930.
  • SB 930 would allow closing times for on-sale retailers to be extended from 2 a.m. to 4 a.m. as part of a dangerous "pilot program."
  • "The data is clear and this is why we must prevent the 4 a.m. bar bill from taking effect in Los Angeles and in California.
  • Alcohol Justice encourages the public to TAKE ACTION to STOP SB 930: Text JUSTICE to 313131 or visit: https://alcoholjustice.org/take-action/stop-sb-930-no-late-last-calls-in...

Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022)

Retrieved on: 
Monday, July 11, 2022 - 1:45pm

Key goal of this course is to understand:

Key Points: 
  • Key goal of this course is to understand:
    Legal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Regulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Implementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recalls
    What to do when a complaint is received:
    Implementing interactive systems between complaint handling, medical device reporting, and CAPA
    Submission of MDR's to the FDA:
    Submission of Vigilance Reports to EU Competent Authorities:
    What to do when a medical device needs to be recalled:
    To discussion of key case studies and how to prevent compliance issues related to Complaint Management, MDR, Vigilance reporting and medical device product recalls
    Anyone that participates in product complaint management, medical device reporting, vigilance reporting, and/or product recalls:

Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 28, 2022 - 3:00pm

Key goal of this course is to understand:

Key Points: 
  • Key goal of this course is to understand:
    Legal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Regulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Implementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recalls
    What to do when a complaint is received:
    Implementing interactive systems between complaint handling, medical device reporting, and CAPA
    Submission of MDR's to the FDA:
    Submission of Vigilance Reports to EU Competent Authorities:
    What to do when a medical device needs to be recalled:
    To discussion of key case studies and how to prevent compliance issues related to Complaint Management, MDR, Vigilance reporting and medical device product recalls
    Anyone that participates in product complaint management, medical device reporting, vigilance reporting, and/or product recalls:

Alcohol Justice: Public Health & Safety Kicked to the Curb Again as California Assembly "GO" Committee Approves Dangerous 4 a.m. Bar Bill Experiment

Retrieved on: 
Thursday, June 23, 2022 - 7:25pm

SAN FRANCISCO, June 23, 2022 /PRNewswire/ -- Alcohol Justice and the California Alcohol Policy Alliance (CAPA) condemned a one-person majority vote of the California State Assembly Governmental Organization Committee (GO) yesterday to allow SB 930 to proceed. The "gut & amend" bill is Senator Scott Wiener's 4th attempt to disrupt the protections of uniform 2 a.m. last call in California by launching a 7-city pilot program to generate nightlife alcohol sales profits at the expense of public health and safety. All of his previous attempts have failed.

Key Points: 
  • The "gut & amend" bill is Senator Scott Wiener's 4th attempt to disrupt the protections of uniform 2 a.m. last call in California by launching a 7-city pilot program to generate nightlife alcohol sales profits at the expense of public health and safety.
  • In reality, SB 930 will spread alcohol overconsumption, loss of life, injury, and nuisance across the state.
  • Last call timeswhat the scientific literature calls "trading hours"are a backbone of maintaining alcohol as a safe and legal product.
  • While the public and all levels of government will be forced to continue to cover the costs of cleaning up the mess that follows.

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control Webinar - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 22, 2022 - 11:08am

The "FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control" webinar has been added to ResearchAndMarkets.com's offering.
  • This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.
  • FDA's guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results.
  • Managing OOT results also helps to avoid time consuming OOS results.

FDAnews Announces: 1 Week Until Effective Root Cause Analysis and CAPA Investigations for the Life Sciences, Virtual Workshop June 28-30, 2022

Retrieved on: 
Tuesday, June 21, 2022 - 6:00pm

FALLS CHURCH, Va., June 21, 2022 /PRNewswire-PRWeb/ -- Effective Root Cause Analysis and CAPA Investigations for the Life Sciences A Virtual Workshop Presented by WCG-FDAnews and ValSource Learning Solutions Tuesday, June 28 – Thursday, June 30, 2022, 11:00 a.m.–4:00 p.m. EDT https://wcg.swoogo.com/root-cause-analytics-capa-investigations-june-2022

Key Points: 
  • Deviations and failures may be a fact of life but understanding what happened, and why, is key to establishing corrective actions and achieving success.
  • Drug and devicemakers will learn how to upgrade their root cause analysis and corrective and preventive action (CAPA) investigations in this virtual workshop.
  • James L. Vesper, PhD, MPH, Director of ValSource Learning Solutions, will lead attendees through a defined, logical process for root cause analysis and CAPA investigations that can be applied in the drug, medical device and clinical trial industries.
  • He will help attendees develop the skills and techniques needed to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence.