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Events / Westside (251)

Wednesday, December 2

Miami Horror

El Rey Theatre

5515 Wilshire Blvd, Los Angeles, CA 90036


Australia’s favourite psychedelic-dance pioneers, Miami Horror, are set to return in 2015 with an assured, neoteric sound to cement their position as innovators in the electronic music world once again.


The past few years have seen the group release their highly anticipated debut, Illumination, to heady acclaim, as well as relocate to the US after touring the world multiple times over. Settling in Los Angeles, the four-piece quickly found inspiration in the glowing year-round Californian sun, set up a home studio and eagerly started experimenting with new sounds and projects to ease their creative itch.


Anchored by producer Ben Plant, the band found it easy to make a home between Melbourne and Los Angeles, mostly due to the elevated number of Australian artists such as Bag Raiders, Anna Lunoe and Empire of the Sun, along with friendly LA natives like Classix and Ariel Pink, helping the band to quickly settle in.


“We’ve found there was a strong scene and vibe in LA, if you look at a lot of the alternative electronica and dance music coming from there it definitely has a sound – we love the weirdness and sunshine. It has been a strong influence on many of our favorite records and we wanted to allow the place to influence this record, and it definitely has.”

Spending the last three years crafting and perfecting new material glittered with dream-gazey synth and a matured approach to songwriting, has delivered a new chapter in Miami Horror’s evolution. Providing insight into what is yet to come, anthemic singles ‘Real Slow’, ‘Colours In The Sky’ and ‘Wild Motion (Set It Free)’, show off polished production with attention to detail that references their Australian context, but re-establishes Miami Horror as an indie-electronica act at the forefront of the genre internationally.

Now ready with a huge second studio album, All Possible Futures is the result of the many dedicated sessions everywhere from Melbourne, Los Angeles, Paris and New York, to cumulate a glowing collection of drifting electronica-infused new-wave that marks a definite coming of age for the band.

“When I wrote the first record my musical influence was a quarter of what it is now. Illumination was written mostly between the ages of 21 to 23 and it came out when I was 24, so this record reflects a big difference in terms of maturity.”

Armed with Plant’s ripened perspective, the band have effortlessly defined a new direction in their sound with All Possible Futures, with the record showcasing an eclectic mix of influences from the Post-Disco and punk of Talking Heads, New Order and INXS, through to the pop influence of Michael Jackson, Paul Simon, Tears For Fears and the dreamy aesthetic of Fleetwood Mac; scattered across all 15 tracks.

Plant describes the production process as one that was key to ensuring longevity and a sense of permanence for the new album, a medium which they feel is still necessary for creating a story, and an emotional connection with music.

“We wanted to make something that lasts and grows the more you listen to it; we found a lot of fans overseas had been listening to our first album for years and that’s what made us realise the importance of making something permanent. We wanted to make an album that you could listen to over five years and still discover new sounds or favourite songs.” On the current state of the industry, Plant goes further to explain that a shift in how people consume music affected the new album’s meaning. “We’ve seen the album format quiver and turn to a focus on artists writing one-off hits. We personally love albums and the story they can tell. A great album will still always stand out in history. Just like the boom of disco singles in the ‘70s and then again with house music, we feel like this is a time where a lot of tracks will be lost amongst sands of time.”

Proving that time and introspective is key to creating their art, Miami Horror’s eclectic mix of influences, experimentation with developed songwriting, and inspired new focus on identity has resulted in a progressive and heart-felt collection of songs that aim to break the mould and challenge the traditional constraints of physical time and space. A sensory voyage from start to finish, 2015 belongs to Miami Horror.

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Thursday, December 3

Seminar on Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach - St. Pet

Courtyard St. Petersburg Downtown

300 4th St N, St Petersburg, Florida 33701, United States, St Petersburg, Florida, 33701

9:00am to 6:00pm

Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are:
• Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ),
• Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer
• For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program?

Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.
Why should you attend?
Attend this FDA validation seminar to get deep knowledge about:
• How to define a Sustainable Structure of a Firm's Validation Program
• Understand How Change Control and Other Quality Programs Feed Into the Validation Program
• Offer Usable Protocol and Other Validation Program Document Templates
• Define Minimal Recommended Tests and Verifications for
o Equipment Qualification
o Process Validation
o Software Validation
• Common Pitfalls to Avoid When Executing Validation Protocols
• How to Estimate Costs and Time Associated with Validation
• How to Respond to Customer and Regulatory Audit Observations Associated with Validation
Areas Covered in the Session:
• Basics Of Validation
• The Components of a Sustainable Validation Program
• Other Programs that Feed the Validation Program (1 Hour)
• Equipment, Utility, and Facility Qualification
• Process Validation
• Software Validation
• Time and Costs of Validation
• Responding to Validation and Other Related Audit Findings
Who will benefit:
• Internal Auditors
• Regulators
• Legal Departments
• Compliance Officers
• Validation Managers
• QC Managers
• QA Managers
• Facilities and Engineering Department Staff
Day 1 Schedule:
Lecture 1: Understanding the Basics of Validation
• Regulatory References
• Validation Terminology
Lecture 2: The Components of a Sustainable Validation Program
• Design Qualification
• FATs and SATs
• Commissioning
• The Validation Master Plan
• The Validation Project Plan
• Standard Operating Procedures (SOPs)
• Protocols
• Reports
• Additional Software Validation Documents
Lecture 3: Other Programs that Feed the Validation Program
• Change Control
• Complaint Handling
• Deviation Management
• Maintenance
• Sales
Lecture 4: Equipment, Utility, and Facility Qualification
• The SOP
• Protocol Template
• Minimal Testing and Verifications for IOQ
• Minimal Testing and Verifications for PQ
• Facility Qualification
• Execution of Protocols
• Report Generation
Lecture 5: Process Validation
• The SOP
• Protocol Template
• Minimal Testing and Verifications
• Execution of Protocols
• Report Generation
Lecture 6: Software Validation
• The SOP
• Protocol Template
• Additional Software Validation Document Templates
• Minimal Testing and Verifications
• Execution of Protocols
• Report Generation
Lecture 7: Time and Costs Associated with Validation
• Estimating Time Associated with Each "Deliverable"
• Hidden Costs of Validation
• Estimating Costs of Using Validation Consultants
• How to Recoup Costs Associated with Validation for Contract Manufacturers
Lecture 8: Responding to Audit Findings Associated with Validation
Day 2 Schedule:
Lecture 9: Welcome and Day 1 Reinforcement
Lecture 10: Practical Application # 1 -Equipment Qualification
Lecture 11: Practical Application # 2 -483 Responses
Lecture 12: Closing Comments
Individual/Open Q&A Session

Jonathan M. Lewis
Principal, Advanced Biomedical Consulting (ABC), LLC

Jonathan M. Lewis Founding Partner, Reliant FDA Experts��...a Division of Advanced Biomedical Consulting, LLC, has over twenty-three years' experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.
Prior to founding Reliant FDA Experts��, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate xDirector of Consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, in Sterility Assurance.
Location: St. Petersburg, Florida Date: December 3rd & 4th, 2015 Time: 9 AM to 6 PM

Venue: Courtyard St. Petersburg Downtown
Address: 300 4th St N, St Petersburg, Florida 33701, United States

Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200.
Until November 15, Early Bird Price: $1,295.00

From November 16 to December 01, Regular Price: $1,495.00

Registration Details:
NetZealous LLC - DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
USA Phone: 1-800-447-9407
Fax: 302-288-6884
[email protected]
Registration Link - http://bit.ly/1PR53NH

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