San Francisco, California
Upcoming Events in San Francisco California
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SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
- Course Description: Formal written Standard Operating Procedures (SOPs) are required both by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and many times are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced.
This two day In-person seminar will provide step by step instructions to create SOPs for FDA-regulated organizations. Throughout the workshop, the instructor will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed.
This workshop contains a collection of practical tips from the instructor’s extensive FDA audit experience. Common questions regarding validation requirements, handling deviations, frequency of review and update, evaluating non-SOP driven processes, global SOPs, and ways to address FDA 483s regarding SOPs will be discussed using sample SOPs.
Regulatory requirements for SOPs
Legal requirements for SOP creation and maintenance
Types of SOPs
Formats and essential components of SOPs
SOP driven process: process mapping
Electronic verses paper SOPs
Who will Benefit:
This workshop will be beneficial for the following personnel in all FDA-regulated organizations such as clinical trials, manufacturing, advertisement, marketing, regulatory affairs, auditing, and laboratory testing:
Supervisors, and lead workers in Regulatory Affairs
Quality Assurance and Quality Control personnel
Clinical investigators, site management and contracting personnel
Clinical trial specialists
People investing in FDA-regulated product development projects
For Registration - http://www.complianceonline.com/sops-for-fda-regulated-industry-seminar-training-80110SEM-prdsm?channel=lasr
Note: Use coupon code < NB5SQH8N > and get 10% off on registration, Valid till Dec 31st 2015
Address: Grand Hyatt San Francisco 345 Stockton Street , San Francisco, California
Spooky Hotel W San Francisco Halloween 2015
- Spooky Hotel W San Francisco Halloween 2015 – Who’s looking for the hottest Halloween haunt? Embrace your alter ego, don your most stylish costume and head to W San Francisco’s “sinister chic” Halloween Happening. Celebrate Halloween in Style at the Haunted W San Francisco located at 181 Third Street, San Francisco, CA 94103. Doors 9pm-2am
W San Francisco turns into a hotel-wide haunted house, featuring San Francisco’s hottest deejays spinning Top 40, Hip Hop, EDM and more. Put on your most creative costume and head to the W San Francisco to party all night. (Skimpy) costumes are encouraged and advance discounted tickets will soon be available online at www.wsfhalloween.com
Limited discounted presale tickets will be made available. For more information, and/or to request to be first notified when tickets www.bottlemenuservice.com, or call (310) 749-9029. Checkout sneak peek at W San Francisco Halloween online at http://www.youtube.com/watch?v=CHlEyaFzH-U
About W San Francisco
Located in the heart of the SoMA district, W San Francisco is the ultimate urban oasis, with panoramic views of the city's skyline and a breathtaking view of the Bay Bridge. W San Francisco's contemporary style mixes local influences inspired by the city's diverse neighborhoods with the W brand's New York-inspired DNA. The Living Room and meeting rooms include sleek metro sleeping pods and a glowing fireplace, a perfect gathering spot for cocktails or an energizing place to work. Premier attractions include TRACE, the hotel's new farm-to-urban-table restaurant that captures the vibrant, local personality of the Bay Area along with a dedication to socially responsible eating. W San Francisco is a home away from home for international jet-setters and the place to be for in-the-know locals.
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W San Francisco New Years 2016
- Revel in the electric energy of W San Francisco. Ring in 2016 with Style and Splendor in celebration of New Year’s Eve 2016 at W San Francisco Hotel on Thursday, 31st December 2015, at 9:00 PM. San Francisco is an extremely popular destination for New Year’s Eve.
Purchase W SF NYE Tickets now to guarantee your biggest, craziest, most decadent New Years’ experience at W San Francisco NYE. Tickets available now online at -- http://ticketvibe.com/wsf
W Hotel SF New Year’s party is the most popular destination in San Francisco to celebrate New Year’s Eve. This NYE event always is slam packed and sold out fast! Revel in the electric energy of W San Francisco. Join us in the Innovative Living Room, Upstairs Bar and Lounge, and Great Room. Don’t miss the Luxury and the life that we all want to experience this New Year’s Eve. Enjoy LIVE deejay sets by San Francisco top deejays while indulging in a four hour sponsored premium hosted bar. Be one of the many privileged VIP guests and indulge in the VIP bar treatment happening at the Exclusive VIP Lounge with private bar and Mixologist!
Your New Year’s Eve plans have been officially set! So get ready for a celebration of sheer nightlife indulgence at its absolute finest. Party favors, surprise pop ups and one massive countdown that will be second to no other in America’s favorite city and world renowned hotel, W San Francisco Hotel. For more information, contact Jamie Barren at (310) 749-9029, or online at www.newyearsnightlife.net
Address: W San Francisco Hotel, 181 3rd St, San Francisco, CA 94103 , San Francisco, California